Citation and commencement
Regulation 1
1These Regulations may be cited as the Medical Devices Regulations 2002 and shall come into force 13th June 2002.
Expiry of certain provisions in these Regulations
Regulation 1ZA
1ZA1Subject to paragraph (3), regulations 19B and 30A cease to have effect at 23:59 on 30 June 2028.2Subject to paragraph (3), regulations 19C, 44ZA and 44ZB cease to have effect at 23:59 on 30 June 2030.3The following cease to have effect at 23:59 on 30 June 2023—aregulation 19B(4), (5), (8) and (9);bregulation 19C(8) and (9);cregulation 30A(4) to (7);dregulation 44ZA(4) and (5);eregulation 44ZB(4) and (5).
Schedules
Regulation 1A
1ASchedules 2 and 2A have effect.
Interpretation
Regulation 2
21 ... In these Regulations ...—...“active implantable medical device” means a medical device which—relies for its functioning on a source of electrical energy or a source of power other than that generated directly by the human body or by gravity; andis intended to be totally or partially introduced into the human body (whether surgically or medically, including being introduced into a natural orifice) and which is intended to remain in the human body after completion of the surgical or medical procedure during which it is introduced,even if it is intended to administer a medicinal product or incorporates as an integral part a substance which, if used separately, would be a medicinal product; ... “approved body” is to be construed in accordance with regulation A45; ......“CE marking” means a conformity marking consisting of the initials “CE”;... “clinical data” means the safety or performance information that is generated from the use of a device, derived from—clinical investigations of the device concerned; orclinical investigations or other studies reported in scientific literature of a similar device for which equivalence to the device in question can be demonstrated; orpublished or unpublished reports on other clinical experiences of either the device in question or a similar device for which equivalence to the device in question can be demonstrated; “coronavirus test device” means an in vitro diagnostic medical device for the detection of the presence of a viral antigen or viral ribonucleic acid (RNA) specific to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); “designated standard” has the meaning given in regulation 3A; “device for performance evaluation” means a product which is intended by its manufacturer to be subject to one or more performance evaluation studies in laboratories for medical analysis or in other appropriate environments outside his own premises; “Directive 90/385” means Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of Member States relating to active implantable devices as it had effect immediately before IP completion day; “Directive 93/42” means Council Directive 93/42/EEC of 14 June 1993 concerning medical devices as it had effect immediately before IP completion day; “Directive 98/79” means Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in-vitro diagnostic medical devices as it had effect immediately before IP completion day;... “Directive 2003/12” means Commission Directive 2003/12 of 3rd February 2003 on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices; ... “Directive 2005/50” means Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices; “Directive 2007/47” means Directive 2007/47/EC of the European Parliament and of the Council amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market;... “... CAB” shall be construed in accordance with regulation 48(1);... ...... “hazard” means a potential source of injury or damage to health; “hip, knee or shoulder replacement” means an implantable component part of a total joint replacement system which is intended to provide a function similar to that of either a natural hip joint, a natural knee joint or a natural shoulder joint, other than ancillary components (screws, wedges, plates and instruments); “intended for clinical investigation” means— intended for use by a registered medical practitioner when conducting investigations of that device in an adequate human clinical environment; orintended for use by any other person in Great Britain who, by virtue of their professional qualification, is authorised to carry out investigations of that device in an adequate human clinical environment;“intended purpose” means—in relation to an active implantable medical device, the use for which it is intended and for which it is suited according to the data supplied by the manufacturer in the instructions relating to it;in relation to any other medical device, the use to which the device is intended according to the data supplied by the manufacturer on the labelling, the instructions for use and/or the promotional materials;“in vitro diagnostic medical device” means a medical device which—is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination; andis intended by the manufacturer to be usedin vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information—concerning a physiological or pathological state,concerning a congenital abnormality,to determine the safety and compatibility of donations, including blood and tissue donations, with potential recipients, orto monitor therapeutic measures,and includes a specimen receptacle but not a product for general laboratory use, unless that product, in view of its characteristics, is specifically intended by its manufacturer to be used forin vitro diagnostic examination; “machinery” has the meaning given to it by regulation 4 of the Supply of Machinery (Safety) Regulations 2008; “manufacturer” means—the person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party; orany other person who assembles, packages, processes, fully refurbishes or labels one or more ready-made products or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name, apart from a person who assembles or adapts devices already on the market to their intended purpose for an individual patient;“medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnosis or therapeutic purposes or both and necessary for its proper application, which—is intended by the manufacturer to be used for human beings for the purpose of-diagnosis, prevention, monitoring, treatment or alleviation of disease,diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,investigation, replacement or modification of the anatomy or of a physiological process, orcontrol of conception; anddoes not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, even if it is assisted in its function by such means,and includes devices intended to administer a medicinal product or which incorporate as an integral part a substance which, if used separately, would be a medicinal product and which is liable to act upon the body with action ancillary to that of the device;“the Medical Devices Directives” means Directive 90/385, Directive 93/42, both read with Regulation (EU) No 207/2012 and Regulation (EU) No 722/2012 and Directive 98/79;...“medicinal product” has the meaning given in regulation 2(1) of the Human Medicines Regulations 2012; “mutual recognition agreement” means an agreement that—is between the United Kingdom and a country listed in Schedule 2, andcovers matters including the conditions under which the United Kingdom and that country will accept or recognise the results of conformity assessment procedures undertaken by the each other's designated bodies;... ... ...“placing on the market” means, in relation to a medical device, the first making available in return for payment or free of charge of a new or fully refurbished device, other than a device intended for clinical investigation, with a view to distribution, use, or both, on the Great Britain market and related expressions must be construed accordingly;“putting into service” means—in relation to an active implantable medical device, the making available of the device to a registered medical practitioner for implantation;in relation to any other medical device, the first making available of the device in Great Britain to a final user, including where a device is used in a professional context for the purposes of medical analysis without being marketed; “Regulation (EU) No 207/2012” means Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices;(as retained under section 3 of the European Union Withdrawal Act 2018 and modified under section 8 of that Act) “Regulation (EU) No 722/2012”— in Part 4A, has the meaning given in regulation 44ZC;in all other Parts means Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin (as retained under section 3 of the European Union (Withdrawal) Act 2018 and modified under section 8 of that Act); “Regulation (EU) 2017/745” means Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC; “Regulation (EU) 2017/746” means Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU; “Regulation (EU) 2022/1107” means Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council; “relevant essential requirements”—in Part 4A, has the meaning given in regulation 44ZC;in all other Parts, in relation to a medical device, means the essential requirements set out in Annex 1 of Directive 90/385, Annex I of Directive 93/42 or Annex I of Directive 98/79 which apply to it, but not including, in the case of a device intended for clinical investigation, such of those requirements, or aspects of them, as are the subject of the investigation;“specimen receptacle” means a medical device which (whether vacuum-type or not) is specifically intended by its manufacturer to be used for the primary containment and preservation of specimens derived from the human body for the purpose ofin vitro diagnostic examination;“stable derivatives device” means a medical device that contains human blood, blood products, plasma or blood cells of human origin, and which incorporates, as an integral part, a substance which—if used separately, may be considered to be a medicinal product constituent or a medicinal product derived from human blood or human plasma within the meaning of regulation 2(2) of the Human Medicines Regulations 2012; andis liable to act upon the human body with action ancillary to that of the device; “statistical review” means a review of the statistical sections of the written notice which a manufacturer or their UK responsible person submits to the Secretary of State pursuant to regulation 16(1) or 29(1) in respect of an intended clinical investigation of a relevant device; “supply”, in relation to a medical device, means—the supply of, or the offer or agreement to supply, the device; orthe exposure or possession for supply of the device; “third country conformity assessment body” means a body established in a country which is listed in Schedule 2 and designated in accordance with a relevant mutual recognition agreement to carry out conformity assessment procedures for the purposes of these Regulations; ... “UK marking” has the meaning given in Article 2(22) of Regulation (EC) No 765/2008;... “UK responsible person” means a person established in any part of the United Kingdom who acts on behalf of a manufacturer established outside the United Kingdom in relation to specified tasks with regard to the manufacturer's obligations under these regulations; and “working day” means any day which is not Saturday, Sunday, Christmas Day, Good Friday or a day which is a bank holiday in any part of Great Britain under the Banking and Financial Dealings Act 1971. 1AIn these Regulations, any reference to Annexes 1 to 7 to Directive 90/385, Annexes I to X to Directive 93/42 or Annex I to X to Directive 98/79 is to be construed as a reference to those Annexes as they applied immediately before IP completion day and as modified by Schedule 2A. 1BIn these Regulations, any reference to Annex 1 to Directive 90/385 or to Annex I to Directive 93/42 is to that Annex read with Regulation (EU) No 207/2012.2In these Regulations, unless the context otherwise requires, a reference—ato a numbered regulation, Part or Schedule is to the regulation or Part of, or the Schedule to, these Regulations bearing that number;bin a regulation to a numbered or lettered paragraph is to the paragraph of that regulation bearing that number or letter; andcin a paragraph to a numbered or lettered sub-paragraph is to the sub-paragraph in that paragraph bearing that number or letter.
Medical devices which are qualifying Northern Ireland goods
Regulation 2A
2A1 Subject to paragraph (1A), notwithstanding the effect of regulations 19B, 19C, 30A, 44ZA and 44ZB and the expiry of the period during which those regulations apply by virtue of regulation 1ZA, any medical device—awhich meets the requirements of—ithese Regulations as they apply in Northern Ireland;ii Regulation (EU) 2017/745; oriii Regulation (EU) 2017/746; andbwhich is a qualifying Northern Ireland good,may be placed on the Great Britain market as if it meets the requirements of these Regulations as they apply in Great Britain.1ABefore 25 July 2024, paragraph (1) only applies to a coronavirus test device that meets the requirements of Regulation (EU) 2017/746 if the device also meets the requirements of—aregulation 34A (approval requirement for coronavirus test devices); orbthe common specifications set out in Annex I and XIII to Regulation (EU) 2022/1107.2In this regulation, a “qualifying Northern Ireland good” has the meaning given in regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018;b“Regulation (EU) 2017/745” means Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.
Scope of these Regulations
Regulation 3
3These Regulations shall not apply to—amedicinal products governed by the Human Medicines Regulations 2012 (including medicinal products derived from human blood or human plasma ...);bhuman blood, human blood products, plasma or blood cells of human origin;cdevices that incorporate, at the time of placing on the market, human blood, blood products, plasma or blood cells of human origin, except for —istable derivatives devices,iiactive implantable medical devices and accessories to such devices, andiii in vitro diagnostic medical devices and accessories to such devices,;dtransplants or tissues or cells of human origin or products incorporating or derived from tissues or cells of human origin , except for ..., in vitro diagnostic medical devices and accessories to such devices save where medicinal products are incorporated as ancillary to the device;etransplants or tissues or cells of animal origin, unless—ia device is manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue, oriia product is ... an in vitro diagnostic medical device, or an accessory to such a device;fcosmetic products governed by Regulation (EC) 1223/2009 of the European Parliament and of the Council of 30th November 2009 on cosmetic products; org. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Revocation, transitional and saving provisions in respect of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
Regulation 3ZA
3ZA1Subject to paragraph (2), Parts 2 to 7 only apply in Northern Ireland for the purpose of regulating qualifying devices.2The following provisions continue to apply in Northern Ireland in accordance with this paragraph ...—afor the purposes of the registration of medical devices (whether or not they are qualifying devices) and persons placing medical devices on the market in Northern Ireland—iregulation 19 (registration of persons placing general medical devices on the market),iiregulation 21B (registration of persons placing active implantable medical devices on the market),iiiregulation 44 (registration of persons placing in vitro diagnostic medical devices on the market or for performance evaluation), andivregulation 53 (fees in connection with the registration of devices and changes to registration details),only apply until the date which is 24 months after the date of publication of the notice referred to in Article 34(3) of Regulation (EU) 2017/745;aaregulations 34A to 34D, 38A to 38C, 39A, 56A, 59 and 61 continue to apply in relation to coronavirus test devices whether or not they are qualifying devices;bParts 5 to 7 also apply for purposes related to the designation of conformity assessment bodies for the purposes of a UK mutual recognition agreement.3 For the purposes of this regulation, a device is a qualifying device if, by virtue of Article 120 of Regulation (EU) 2017/745 or Article 110 of Regulation (EU) 2017/746—ait may be placed on the market, put into service or made available in Northern Ireland in accordance with the requirements of Directive 90/385, Directive 93/42 or Directive 98/79, rather than Regulation (EU) 2017/745 or Regulation (EU) 2017/746; andbit is placed on the market, put into service or made available in Northern Ireland in accordance with, and subject to the requirements of and the arrangements set out in, Parts 2 ... to 7.
Designated standard
Regulation 3A
3A1 In Parts II, III and IV of these Regulations, a “designated standard” means—aa technical specification which is—iadopted by a recognised standardisation body or an international standardising body, for repeated or continuous application with which compliance is not compulsory; andiidesignated by the Secretary of State by publishing a reference to the standard and maintaining that publication in a manner the Secretary of State considers appropriate; orba monograph of the European Pharmacopoeia (in particular on surgical sutures and on the interaction between medicinal products and materials used in devices containing medicinal products) which has been published in the Official Journal of the European Union.2For the purposes of paragraph (1), a “technical specification” means a document which prescribes technical requirements to be fulfilled by a device, process, service or system (“the product”) and which lays down—athe characteristics required of a product, including levels of quality, performance, interoperability, environmental protection, health and safety and dimensions;bthe requirements applicable to the product as regards the name under which the product is sold, terminology, symbols, testing and test methods, packaging, marking or labelling and conformity assessment procedures; andcthe production methods and processes relating to the product, where these have an effect on its characteristics.3For the purposes of this regulation a “recognised standardisation body” means any one of the following organisations—athe European Committee for Standardisation (CEN);bthe European Committee for Electrotechnical Standardisation (CENELEC);cthe British Standards Institute (BSI).3AIn this regulation “international standardising body” has the same meaning as it has for the purposes of the Agreement on Technical Barriers to Trade, part of Annex 1A to the agreement establishing the World Trade Organisation signed at Marrakesh on 15 April 1994 (as modified from time to time).4When considering whether the manner of publication of a reference is appropriate in accordance with paragraph (1)(b), the Secretary of State must have regard to whether the publication will draw the standard to the attention of any person who may have an interest in the standard.5Before publishing the reference to a standard in relation to a technical specification which has been adopted by BSI, the Secretary of State must have regard to whether the technical specification is consistent with such technical specifications adopted by the other recognised standardisation bodies or by international standardising bodies as the Secretary of State considers to be relevant.6The Secretary of State may remove from publication the reference to a standard which has been published in accordance with paragraph (1)(b).7Where the Secretary of State removes the reference to a standard from publication, that standard is no longer a designated standard.8 In this regulation—aa reference to a “device” is a reference to a medical device or its accessory or an in vitro diagnostic medical device or its accessory to which these Regulations apply;ba reference to “the European Pharmacopoeia” is a reference to the European Pharmacopoeia adopted in accordance with the Convention on the Elaboration of a European Pharmacopoeia.
Confidentiality
Regulation 3B
3B. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Transitional provisions
Regulation 4
41Part II shall not be applied before 1st July 2004 in respect of a device which has been subjected to EEC pattern approval before 1st January 1995 in accordance with the Clinical Thermometers (EEC Requirements) Regulations 1993 .2Part II shall not be applied—abefore 10th January 2007 in respect of a stable derivatives device placed on the market without a CE marking, if the device satisfies the requirements of the laws of that part of the United Kingdom in which it is placed on the market as in force on 10th January 2002; orbbefore 10th January 2009 in respect of a stable derivatives device put into service without a CE marking, if the device satisfies the requirements of the laws of that part of the United Kingdom in which it is placed on the market as in force on 10th January 2002.3Part IV shall not be applied before 7th December 2003 in respect of a device placed on the market which is—aanin vitro diagnostic medical device without a CE marking; orba device for performance evaluation and the manufacturer or his authorised representative does not indicate, directly or indirectly, that it is a device which is subject to the provisions of these Regulations,if the device satisfies the requirements of the laws of that part of the United Kingdom in which it is placed on the market as in force on 7th December 1998.4Part IV shall not be applied before 7th December 2005 in respect of a device put into service which is—aanin vitro diagnostic medical device without a CE marking; orba device for performance evaluation and the manufacturer or his authorised representative does not indicate, directly or indirectly, that it is a device which is subject to the provisions of these Regulations,if the device satisfies the requirements of the laws of that part of the United Kingdom in which it is put into service as in force on 7th December 1998.5Regulation 13(4) shall not be applied before 1st March 2004 in respect of breast implants which—abore a CE marking before 1st September 2003; andbsatisfy the requirements in respect of relevant devices falling within Class IIb set out in regulation 13(3).6Regulation 19A shall not be applied before 1st October 2004 in respect of a device placed on the market before 1st April 2004.
Transitional provisions for hip, knee and shoulder replacements
Regulation 4A
4A1This regulation applies to hip, knee or shoulder replacements.2Regulation 13(4) shall not apply in respect of a replacement—awhose manufacturer or his authorised representative has before 1st September 2007—ifulfilled the applicable obligations imposed by Annex II, excluding Section 4 of that Annex,iideclared, in accordance with a declaration of conformity procedure set out in that Annex, that the device meets the provisions of Directive 93/42 which apply to it, andiiiensured that the device meets the provisions of Directive 93/42 which apply to it; andbin respect of which an examination under Section 4 of Annex II has been carried out and an EC design-examination certificate under that Section has been issued before 1st September 2009.3Regulation 13(4) shall not apply before 1st September 2009 in respect of a replacement—awhose manufacturer or his authorised representative has—ifulfilled the applicable obligations imposed by Annex II, excluding Section 4 of that Annex,iideclared, in accordance with a declaration of conformity procedure set out in that Annex, that the device meets the provisions of Directive 93/42 which apply to it, andiiiensured that the device meets the provisions of Directive 93/42 which apply to it; andbwhich is covered by the decision of a notified body issued in accordance with Section 3.3 or 3.4 of Annex II before 1st September 2007.4Regulation 13(4) shall not apply before 1st September 2010 in respect of replacement—awhose manufacturer or his authorised representative has—ifulfilled the applicable obligations imposed by Annex III together with Annex VI,iideclared, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of Directive 93/42 which apply to it, andiiiensured that the device meets the provisions of Directive 93/42 which apply to it; andbwhich is covered by the decision of a notified body issued in accordance with Section 3.3 or 3.4 of Annex VI before 1st September 2007.5Regulation 13(4) shall not apply in respect of a replacement which—asatisfies the conditions set out in paragraph (4)(a) and (b);bhas been placed on the market before 1st September 2010; andbis put into service on or after that date.
Revocations, transitional and saving provisions in respect of the new national registration requirements
Regulation 4D
4D1Regulation 19 is revoked on the day that is 4 months after IP completion day (which is when regulation 7A comes into force).2Regulation 7A does not apply until the day that is 8 months after IP completion day in respect of a device or accessory—a that is a relevant device for the purposes of Part II; andbthat is classified as belonging to—iClass IIa, as referred to in regulation 7, oriiClass IIb, as referred to in regulation 7, and is also a Group A device (within the meaning given in regulation 52(1)).3Regulation 7A does not apply until the day that is 12 months after IP completion day in respect of a device or accessory—a that is a relevant device for the purposes of Part II; andbthat is classified as belonging to Class I, as referred to in regulation 7.4Where regulation 7A does not apply in respect of a device or accessory by virtue of paragraph (2) or (3), regulation 19 continues to have effect after its revocation in respect of that device or accessory.6Regulation 30(3) is revoked on the day that is 4 months after IP completion day (which is when regulation 21A comes into force).8Regulation 44 is revoked on the day that is 4 months after IP completion day (which is when regulation 33A comes into force).9Regulation 33A does not apply until the day that is 8 months after IP completion day in respect of a device or accessory—a that is a relevant device for the purposes of Part IV, orbthat is—ireferred to in List B, mentioned in regulation 40(4), oriia device for self-testing (as defined in relation 32(1)).10 Regulation 33A does not apply until the day that is 12 months after IP completion day in respect of a device or accessory that is a relevant device for the purposes of Part IV which follows the procedure in regulation 40(1).11Where regulation 33A does not apply in respect of a device or accessory by virtue of paragraph (9), regulation 44 continues to have effect after its revocation in respect of that device or accessory.
Revocation of Commission Decision 2002/364 on 26th May 2025 and its effect before that date
Regulation 4H
4H. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Revocation of Commission Decision 2010/227
Regulation 4I
4ICommission Decision 2010/227/EU of 19 April 2010 on the European Databank on Medical Devices (Eudamed) is revoked.
Revocation of Commission Regulation (EU) No 207/2012 on 26th May 2025
Regulation 4J
4J. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Revocation of Regulation (EU) No 722/2012 on 26th May 2025
Regulation 4K
4K. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Revocation of Regulation (EU) No 920/2013 on 26th May 2025 and its effect before that date
Regulation 4L
4L. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Revocation of Regulation (EU) No 2017/2185 and saving provision
Regulation 4M
4M1Insofar as it is retained EU law, Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council (“Regulation (EU) No 2017/2185”) is revoked.
The classification criteria in Directives 2003/12 and 2005/50
Regulation 4N
4N. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Revocation of Regulation (EU) 2017/745
Regulation 4O
4O1Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (“the Medical Devices Regulation”) (insofar as it is retained EU law) is revoked.
Revocation of Regulation (EU) 2017/746
Regulation 4P
4P1Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (“the in vitro diagnostic medical devices Regulation”) (insofar as it is retained EU law) is revoked.
References in other legislation to Directives 90/385, 93/42 and 98/79
Regulation 4T
4T1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2In regulation 10(5) of the Medicines (Products for Human Use) (Fees) Regulations 2016 (fee for advice for other purposes)—athe reference to the expression “medical device” having the meaning given in Article 1(2)(a) of Directive 93/42 is to be construed, to the extent necessary for the practical application of that definition, as a reference also or instead to having the meaning given in regulation 2; andb. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .cthe reference to the expression “Directive 93/42/EEC” is to be construed, to the extent necessary for the practical application of that expression, as a reference also or instead to Part II of the Medical Devices Regulations 2002;dthe references to “paragraph 4.3 of Annex II to Directive 93/42/EEC” and “paragraph 5 of Annex III to Directive 93/42/EEC” are to be construed, to the extent necessary for the practical application of those provisions, as references also or instead to those paragraphs and those Annexes as they applied immediately before IP completion day and as modified by Schedule 2A.3In Schedule 1 to the Pressure Equipment (Safety) Regulations 2016 (excluded pressure equipment and assemblies), the reference in paragraph 1(f)(iv) to not being covered by Directive 93/42 is to be construed, to the extent necessary for the practical application of that provision, as a reference also or instead to not being covered by Part II.4In regulation 2 of the Waste Electrical and Electronic Equipment Regulations 2013 (interpretation)—athe reference to the expression “active implantable medical device” having the meaning given in Article 1(2)(c) of Directive 90/385 is to be construed, to the extent necessary for the practical application of that definition, as a reference also or instead to it having the meaning given in regulation 2 ...;bthe reference to the expression “medical device” having the meaning given in Article 1(2)(a) of Directive 93/42 is to be construed, to the extent necessary for the practical application of that definition, as a reference to it also or instead having the meaning given to it in regulation 2;cthe reference to the expression “accessory” having the meaning given in Article 1(2)(b) of Directive 93/42 is to be construed, to the extent necessary for the practical application of that definition, as also or instead having the meaning given to “accessory” in regulation 5;dthe reference to the expression “in vitro diagnostic medical device” having the meaning given in Article 1(2)(b) of Directive 98/79 is to be construed, to the extent necessary for the practical application of that definition, as having the meaning given to it in regulation 2;ethe reference to the expression “accessory” having the meaning given in Article 1(2)(c) of Directive 98/79 is to be construed, to the extent necessary for the practical application of that definition, as also or instead having the meaning given to “accessory” in regulation 32.5These Regulations are an enactment implementing a relevant Community Directive for the purposes of regulation 4 of the Personal Protective Equipment at Work Regulations (Northern Ireland) 1993 (provision of personal protective equipment).6These Regulations are also an enactment implementing a relevant Community Directive for the purposes of regulation 4(5)(a) of the Personal Protective Equipment at Work Regulations 1992 (provision of personal protective equipment).
PART II — General Medical Devices
Interpretation of Part II
Regulation 5
51In this Part ...—“accessory” means an article which, whilst not being a medical device, is intended specifically by its manufacturer to be used together with a medical device to enable it to be used in accordance with the use of the medical device intended by its manufacturer;“custom-made device” means a relevant device that is—manufactured specifically in accordance with a written prescription of a registered medical practitioner, or other person authorised to write such a prescription by virtue of his professional qualification, which gives, under his responsibility, specific characteristics as to its design; andintended for the sole use of a particular patient,but does not include a mass-produced product which needs to be adapted to meet the specific requirements of the medical practitioner or professional user;“relevant device” shall be construed in accordance with regulation 6;“single-use combination product” means a product which comprises a medical device and medicinal product forming a single integral product which is intended exclusively for use in the given combination and which is not reusable; and“system or procedure pack” has the same meaning as in article 12 of Directive 93/42.2In this Part ..., a reference to a numbered article or Annex is to the article or Annex of Directive 93/42 bearing that number.
Scope of Part II
Regulation 6
6The requirements of this Part in respect of relevant devices apply in respect of medical devices (including stable derivatives devices), accessories to such devices, single-use combination products, and systems and procedure packs, other than—aactive implantable medical devices and accessories to such devices; and bin vitro diagnostic medical devices and accessories to such devices; andcdevices that come within the scope of Directive 93/42 and another Directive (“the other Directive”) issued by one or more of the institutions of the Community, andithe other Directive includes a provision allowing the manufacturer of the device to choose, during a transitional period that has not ended, which set of arrangements applies to it, andiithe manufacturer chooses to follow the set of arrangements in the other Directive.
Classification of general medical devices
Regulation 7
71For the purposes of this Part and Part VI, devices are classified as belonging to Class I, IIa, IIb or III in accordance with the classification criteria set out in Annex IX of Directive 93/42 , read with Directive 2003/12 and Directive 2005/50.2In the event of a dispute between a manufacturer and an approved body over the classification of a device, the matter shall be referred to the Secretary of State, who shall determine the classification of the device in accordance with the classification criteria set out in Annex IX of Directive 93/42 , read with Directive 2003/12 and Directive 2005/50.
Registration of persons placing general medical devices on the market
Regulation 7A
7A1No person may place a relevant device on the market in accordance with this Part unless that person—ais established in Great Britain; andbhas complied with paragraph (2).2A person who places a relevant device on the market complies with this paragraph if, before placing the relevant device on the market—awhere—ithat person is the manufacturer of that device and is based in Great Britain, the person informs the Secretary of State of the address of their registered place of business in Great Britain;iithat person is the manufacturer of that device and is based outside the United Kingdom, the manufacturer appoints a sole UK responsible person, and that UK responsible person provides the Secretary of State with written evidence that they have the manufacturer’s authority to act as their UK responsible person; oriiithat person is not the manufacturer of the device, the address of that person’s registered place of business in Great Britain has been provided to the Secretary of State by the manufacturer or the UK responsible person;bthat person supplies the Secretary of State with a description of the relevant device; andcthat person pays to the Secretary of State the relevant fee in accordance with regulation 53.2AThe person responsible for providing information in accordance with paragraph (2) must inform the Secretary of State of any changes to that information.3 The UK responsible person appointed in accordance with paragraph (2)(a)(ii) must—aensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;bkeep available for inspection by the Secretary of State a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements;cin response to a request from the Secretary of State, provide the Secretary of State with all the information and documentation necessary to demonstrate the conformity of a device;d where they have samples of the device or access to the device, comply with any request from the Secretary of State to provide such samples or access; ewhere they have neither samples of the device nor access to the device, communicate to the manufacturer any request from the Secretary of State to provide such samples or access, and communicate to the Secretary of State whether the manufacturer intends to comply with that request;fcooperate with the Secretary of State on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;gimmediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been appointed;hif the manufacturer acts contrary to its obligations under these Regulations—iterminate the legal relationship with the manufacturer; andiiinform the Secretary of State and, if applicable, the relevant approved body of that termination.4 In this regulation—athe references to “technical documentation” are to be construed in accordance with Annex II, III or VII;bthe references to “declaration of conformity” are to be construed in accordance with Annexes II, IV, V, VI and VII.
Essential requirements for general medical devices
Regulation 8
81Subject to regulation 12, no person shall place on the market or put into service a relevant device unless that device meets those essential requirements set out in Annex I which apply to it and the requirements set out in Regulation (EU) No 722/2012 (if applicable).2Subject to regulation 12, no person shall supply a relevant device—aif that supply is also a placing on the market or putting into service of that device; orbin circumstances where that device has been placed on the market or put into service,unless that device meets those essential requirements set out in Annex I which apply to it and the requirements set out in Regulation (EU) No 722/2012 (if applicable).3Where a hazard exists, devices which are also machinery shall also meet the essential health and safety requirements set out in Part 1 of Schedule 2 to the Supply of Machinery (Safety) Regulations 2008 to the extent to which those essential health and safety requirements are more specific than the essential requirements to Directive 93/42.
Determining compliance of general medical devices with relevant essential requirements
Regulation 9
91In determining which are the relevant essential requirements for a particular relevant device, and whether or not it complies with any of the relevant essential requirements, account shall be taken of its intended purpose.2Where confirmation of conformity with the essential requirements must be based on clinical data, such data must be established in accordance with the requirements set out in Annex X.3In the case of a relevant device which is being or has been put into service—athe essential requirements specified in Sections 8.7 and 13 of Annex I with regard to information on the packaging and on any label are complied with only if such information is in English (whether or not it is also in another language and whether or not the device is for professional use); andbthe essential requirements specified in Sections 11.4 and 13 of Annex I with regard to instructions for use are complied with only if—isuch instructions are in English ...ii. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4A relevant device shall be treated as complying with an essential requirement if it conforms as respects that requirement to a relevant designated standard, unless there are reasonable grounds for suspecting that it does not comply with that requirement.5A custom-made device—ain respect of which the conditions specified in Annex VIII are satisfied; andbin the case of a Class IIa, Class IIb and Class III device, which is accompanied by the statement required by Section 1 of Annex VIII,shall be taken to comply with the relevant essential requirements unless there are reasonable grounds for suspecting that the device does not comply with those requirements.5AWhen a custom-made device is supplied to a patient, the healthcare professional who writes the prescription for the custom-made device shall, in relation to each patient that they supply with such a device—aensure that the patient is aware that they may request the statement containing the information required by Sections 1 and 2 of Annex VIII; andbensure that the statement containing the information required by Sections 1 and 2 of Annex VIII is made available to the patient on request.6Where, in accordance with Section 2.1 of Annex VIII, a manufacturer of a custom-made device, or their UK responsible person, has indicated that specified essential requirements have not been fully met, and has given proper grounds as to why they have not been fully met, those specified essential requirements are no longer to be treated as relevant essential requirements for that device.7A device intended for clinical investigation in respect of which—athe conditions specified in Annex VIII are satisfied;bnotice has been given under regulation 16(1); andceither—ino notice has been given under regulation 16(4) within the period of 60 days there referred to, oriinotice has been given under regulation 16(5),shall be taken to comply with the relevant essential requirements unless there are reasonable grounds for suspecting that the device does not comply with those requirements.8A single-use combination product shall be taken to comply with the relevant essential requirements if the medical device which forms part of that product only complies with the requirements set out in Annex I ... that relate to safety and performance, unless the medicinal product which forms part of that product is liable to act on the human body with action ancillary to that of the medical device, in which case the single-use combination product must comply with all the relevant essential requirements which apply to it.9Where a device is intended by the manufacturer to be used in conjunction with both the provisions in Regulation (EU) 2016/425 of the European Parliament and of the Council of 9th March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC and Directive 93/42, the relevant basic health and safety requirements of Regulation (EU) 2016/425 shall also be fulfilled.
UK marking of general medical devices
Regulation 10
101Subject to regulations 12 and 14, no person shall place on the market or put into service a relevant device unless, where practical and appropriate, that device or its sterile pack bears a UK marking which—ameets the requirements set out in Annex 2 of Regulation (EC) No 765/2008;bis in a visible, legible and indelible form; andcis accompanied by any relevant approved body or conformity assessment body identification number for that device.2Subject to regulations 12 and 14, no person shall supply a relevant device unless, where practical and appropriate, that device or its sterile pack bears a UK marking which—ameets the requirements set out in Annex 2 of Regulation (EC) No 765/2008;bis in a visible, legible and indelible form; andcis accompanied by any relevant approved body or conformity assessment body identification number for that device,if that supply is also a placing on the market or putting into service, or if that supply is of a device that has been placed on the market or put into service.3Subject to regulations 12 and 14, no person shall place on the market or put into service a relevant device unless a UK marking meeting the requirements of Annex 2 of Regulation (EC) No 765/2008, appears on—aany sales packaging for that device; andbthe instructions for use for the device,and that UK marking is accompanied by any relevant approved body or conformity assessment body identification number for that device.4Subject to regulations 12 and 14, no person shall supply a relevant device (if that supply is also a placing on the market or putting into service, or if that supply is of a device that has been placed on the market or put into service) unless a UK marking meeting the requirements of Annex 2 of Regulation (EC) No 765/2008, appears on—aany sales packaging for that device; andbthe instructions for use for the device,and that UK marking is accompanied by any relevant approved body or conformity assessment body identification number for that device.5No person shall affix any mark or inscription to, or provide any information comprising a mark or inscription on—aa relevant device or its sterile pack;bthe instructions for use for a relevant device; orcany sales packaging for a relevant device,which is likely to mislead a third party with regard to the meaning or the graphics of the UK marking or which reduces the visibility or the legibility of the UK marking.6In this regulation, where a device is required to bear a UK marking which meets the requirements of Annex 2 of Regulation (EU) No 765/2008, the requirement as to the minimum size of the UK marking specified in section 3 of that Annex is to be understood—aas not applying where, having regard to the small size of the device, it is not possible for the device to bear a marking of that minimum size; andbas allowing a device to bear a UK marking of a size less than that minimum size provided that mark continues to meet the requirements as to visibility, legibility and indelibility in paragraphs (1) and (2).
UK(NI) indication: general medical devices
Regulation 10A
10A1Where the CE marking referred to in regulation 10 is affixed on the basis of an assessment or a certificate issued by a notified body established in the United Kingdom, a UK(NI) indication must be affixed in relation to the device, in accordance with this regulation.2The UK(NI) indication must be affixed—avisibly, legibly and indelibly; andbbefore a relevant device is placed on the market in Northern Ireland.3The UK(NI) indication must accompany the CE marking, wherever such marking is affixed in accordance with regulation 13.3AThe UK(NI) indication may be less than 5mm high provided that it is the same height as the CE marking that it accompanies.4The UK(NI) indication must be affixed by the manufacturer.5Anyone who places a medical device on the market in Northern Ireland must ensure that the manufacturer has complied with their obligations under this regulation.6No person shall supply a relevant device unless the manufacturer has affixed a UK(NI) indication as required by this regulation, if that supply is also a placing on the market or putting into service, or that supply is of a device that has been placed on the market or put into service.
UK marking of general medical devices that come within the scope of this Part and other legislation
Regulation 11
11Where a relevant device (within the meaning of this Part) comes within the scope of this Part and other product safety or health and safety legislation (“the other legislation”) a person must not affix a UK marking to the device unless the relevant requirements of the other legislation are also satisfied.
Exemptions from regulations 8 and 10
Regulation 12
121A relevant device or a single use combination product being shown at a trade fair, exhibition, demonstration or similar gathering is not being placed on the market or put into service if a visible sign clearly indicates that the device or product cannot be marketed or put into service until it complies with the requirements of ... these Regulations.2Regulation 10 shall not apply to a custom-made device or a device intended for clinical investigation.3Regulation 10 shall not apply to a relevant device which is a system or procedure pack, unless—athe system or procedure pack incorporates a medical device which does not bear a UK marking; orbthe chosen combination of medical devices is not compatible in view of their original intended use.4Regulation 10 shall not apply to single-use combination products, unless the medicinal product which forms part of that product is liable to act on the human body with action ancillary to that of the medical device which forms part of that product.5Regulations 8 and 10 shall not apply where, following a duly justified request and in the interests of the protection of health, the Secretary of State has authorised, where appropriate for a specified period, the placing on the market or putting into service of a particular relevant device or relevant devices of a particular class or description without a UK marking, where appropriate subject to conditions (which are complied with), and has not withdrawn that authorisation.6Regulations 8 and 10 do not apply where the Secretary of State directs that a relevant device, or a class of relevant devices, which meets other requirements or standards, or which is marked other than with a UK marking, which the Secretary of State determines is equivalent to the requirements and standards imposed by regulations 8 and 10, may be placed on the market. 7In paragraph (6), the Secretary of State, in determining whether another standard or requirement or marking (“the other standard”) is equivalent to a standard or requirement imposed by regulations 8 and 10, must be satisfied that the other standard imposes a degree of safety and quality equivalent to that imposed by those regulations.
Procedures for affixing a UK marking to general medical devices
Regulation 13
131A relevant device falling within Class I may bear a UK marking only if its manufacturer or their UK responsible person—afulfils the applicable obligations imposed by Annex VII;bdeclares, in accordance with the declaration of conformity procedure set out in that Annex, that the device meets the provisions of this Part which apply to it; andcensures that the device meets the provisions of this Part which apply to it.2A relevant device falling within Class IIa may bear a UK marking only if its manufacturer or their UK responsible person—afulfils the applicable obligations imposed by—iAnnex II, excluding Section 4 of that Annex, oriiAnnex VII, together with Annex IV, V or VI;bdeclares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of this Part which apply to it; andcensures that the device meets the provisions of this Part which apply to it.3A relevant device falling within Class IIb may bear a UK marking only if its manufacturer or their UK responsible person—afulfils the applicable obligations imposed by—iAnnex II, excluding Section 4 of that Annex, oriiAnnex III, together with Annex IV, V or VI;bdeclares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of this Part which apply to it; andcensures that the device meets the provisions of this Part which apply to it.4A relevant device falling within Class III may bear a UK marking only if its manufacturer or their UK responsible person—afulfils the applicable obligations imposed by—iAnnex II, oriiAnnex III, together with Annex IV or V;bdeclares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of this Part which apply to it; ...censures that the device meets the provisions of this Part which apply to it; and dfulfils the obligations imposed by Regulation (EU) No 722/2012 (if applicable).5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Procedures for systems and procedure packs, and for devices to be sterilised before use
Regulation 14
141Subject to paragraph (3), no person shall supply a system or procedure pack (if that supply is also a placing on the market, or if that supply is of a system or procedure pack that has been placed on the market) unless—athe medical devices in that system or procedure pack are for use within their intended purpose and within the limits of use specified by their manufacturer;bthe person who places or has placed it on the market has drawn up a declaration that—ihe has verified the mutual compatibility of the medical devices in that system or procedure pack in accordance with the manufacturers’ instructions, and he has carried out his operations in accordance with these instructions,iihe has packaged the system or procedure pack and supplied relevant information to users incorporating relevant instructions from the manufacturers, andiiihis production of the system or procedure pack is subjected to appropriate methods of internal control and inspection,and that declaration is true at the time it is made and continues to be true.2Subject to paragraph (3), no person shall supply—aa system or procedure pack which was sterilised before being placed on the market; orba relevant device (including a system or procedure pack) which is designed by its manufacturer to be sterilised before use,(if that supply is also a placing on the market, or if that supply is of a device that has been placed on the market) unless the person who places, or who has placed, the device on the market satisfies the conditions set out in paragraph (4).3Paragraphs (1) and (2)(a) shall only apply to a system or procedure pack if, by virtue of regulation 12(3), regulation 10 does not apply to that system or procedure pack.4The conditions referred to in paragraph (2) are that the person shall—afollow the procedures referred to in either Annex II or IV that relate to obtaining sterility; andbif the device has been sterilised, make a written declaration that sterilisation has been carried out in accordance with the manufacturer’s instructions.4AThe application of Annex II or IV and the intervention of the approved body are limited to the aspects of the procedure relating to the obtaining of sterility until the sterile package is opened or damaged.5Where a conformity assessment procedure is carried out in respect of a relevant device (including a device which is a system or procedure pack) pursuant to this regulation—ano person shall affix a UK marking to that device as a result of that procedure; andbno person shall supply that device (if that supply is also a placing on the market, or if that supply is of a device that has been placed on the market) unless it is accompanied by the information referred to in Section 13 of Annex I, which shall include, where appropriate, the information supplied by the manufacturers of the devices which have been put together.6The declarations referred to in paragraph (1)(b) and (4)(b) shall be kept available for the Secretary of State by the person responsible for placing the product on the market for a period of five years.
Procedures for custom-made general medical devices
Regulation 15
15No person shall supply a custom-made device (if that supply is also a placing on the market, or if that supply is of a custom-made device that has been placed on the market) unless its manufacturer or their UK responsible person—ahas drawn up a statement containing the information required by Sections 1, 2 and 2.1 of Annex VIII , read with Regulation (EU) No 722/2012;bhas undertaken to keep available for the Secretary of State documentation allowing an understanding of the design, manufacture and performances of the device, including the expected performances, so as to allow assessment of conformity of the device with the requirements of Directive 93/42; andctakes all necessary measures to ensure that the manufacturing process ensures that each device manufactured according to that process conforms to the documentation referred to in the first paragraph of Section 3.1 of Annex VIII; ...dkeeps available for the Secretary of State, for a minimum period of five years, the information contained in the statement referred to in paragraph (a) and in the undertaking referred to in paragraph (b) ; andeensures that the statement is passed on with the custom-made device so that it may be made available to the patient on request.
Procedures for general medical devices for clinical investigations
Regulation 16
161Subject to paragraph (2), no person shall supply a relevant device (if that supply is also a making available of the device) for the purposes of a clinical investigation in Great Britain unless, before he does so, the manufacturer of the device or their UK responsible person has given at least 60 days prior notice in writing to the Secretary of State of the intended investigation, in the form of—asubject to paragraph (3), the statement required by Sections 1 and 2.2 of Annex VIII , read with Regulation (EU) No 722/2012; andban undertaking to keep available for the Secretary of State the documentation referred to in Section 3.2 of Annex VIII for a minimum period of five years.1AA manufacturer or their UK responsible person may request a meeting with the Secretary of State in advance of giving notice in writing to the Secretary of State pursuant to paragraph (1) in order to—aobtain advice on regulatory requirements relating to an intended clinical investigation; orbobtain a statistical review in relation to an intended clinical investigation.2Paragraph (1) shall not apply in respect of an intended clinical investigation of a relevant device that bears a UK marking otherwise than in breach of regulation 13, unless the aim of the intended investigation is to determine whether the device may be used for a purpose other than that in respect of which it was UK marked in accordance with regulation 13.3The ethics committee opinion that forms part of the information required under Section 2.2 of Annex VIII need not be provided to the Secretary of State at least 60 days prior to the intended investigation, but if it is not provided at least 60 days prior to the intended investigation, it must be provided to the Secretary of State by the manufacturer or their UK responsible person as soon as it becomes available.4If, within 60 days of the formal acceptance by the Secretary of State of the notice in writing given pursuant to paragraph (1), the Secretary of State gives written notice to the manufacturer or UK responsible person (whichever gave the notice pursuant to paragraph (1)) that, on grounds of public health or public policy, the relevant device should not be made available for the purposes of the intended investigation, no person shall supply the relevant device (if that supply is also a making available of the device) for those purposes.5The Secretary of State may, in respect of notice in writing given by a manufacturer or their UK responsible person pursuant to paragraph (1), give written notice to the manufacturer or their UK responsible person—athat the relevant device may be made available for the purposes of the intended investigation; orbif the ethics committee opinion required under Section 2.2 of Annex VIII is not available, that the relevant device may be made available for the purposes of the intended investigation once a favourable opinion in respect of the investigational plan for the intended investigation has been delivered by the committee.6A written notice pursuant to paragraph (5) may—awhere appropriate be given subject to conditions imposed by the Secretary of State, which are to be included in the notice;bat any time be withdrawn on grounds of public health or public policy by the Secretary of State.7Where a written notice pursuant to paragraph (5) in respect of a relevant device has been withdrawn by the Secretary of State—afurther clinical use of the relevant device in the investigation is prohibited; andbno person shall supply that relevant device for the purposes of the investigation (if that supply is also a making available of the device),unless the Secretary of State issues a further written notice pursuant to that paragraph stating that the relevant device may again be made available for the purposes of the investigation.8The manufacturer of a relevant device intended for clinical investigation to which paragraph (1) applies, or their UK responsible person, shall—atake all necessary measures to ensure that the manufacturing process for the relevant device produces devices manufactured in accordance with the documentation referred to in the first paragraph of Section 3.2 of Annex VIII;bauthorise the assessment, including audit where necessary, of the effectiveness of the measures which he takes pursuant to this regulation; andckeep the information contained in the statement and the undertaking referred to in paragraph (1) for a minimum period of five years.9The grounds of public health or public policy referred to in paragraph (4) or (6)(b) are met, amongst other reasons, if—athe manufacturer or their UK responsible person does not authorise an assessment by the Secretary of State, whether by means of an audit, an inspection or otherwise, of the effectiveness of the measures referred to in paragraph (8); orbthe manufacturer or their UK responsible person does not make available to the Secretary of State documentation which he has undertaken to keep available in accordance with paragraph (1)(b).10No person shall conduct a clinical investigation of a relevant device—aotherwise than in accordance with Annex X; andbotherwise than in accordance with any conditions imposed by the Secretary of State pursuant to paragraph (6)(a),and if a clinical investigation is conducted in respect of a relevant device, the manufacturer of that device or their UK responsible person shall keep available for the Secretary of State the report referred to in Section 2.3.7 of Annex X.11The manufacturer, or their single UK responsible person, shall—anotify the Secretary of State of the end of the clinical investigation; andbprovide justification where premature termination has resulted.
Manufacturers etc. and conformity assessment procedures for general medical devices
Regulation 17
171A manufacturer of a relevant device or, where applicable, their UK responsible person who is required to follow, or follows or has followed a conformity assessment procedure set out in this Part shall observe the manufacturer’s obligations set out in that procedure that apply to him.2A manufacturer of a relevant device or, where applicable, their UK responsible person shall, when following a conformity assessment procedure, take account of the results of any assessment or verification operations which have been carried out in accordance with this Part at an intermediate stage of manufacture of the device.3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Approved bodies and the conformity assessment procedures for general medical devices
Regulation 18
181 An approved body which is responsible for carrying out a conformity assessment procedure in relation to a relevant device shall, when carrying out the procedure—atake account of the results of any assessment or verification operations which have been carried out ... at an intermediate stage of manufacture of the device;btake account of any relevant information relating to the characteristics and performance of that device, ...; andclay down, by common accord with the manufacturer or his authorised representative, the time limits for completion of the assessment and verification operations referred to in Annex II to IV.2Where an approved body takes a decision in accordance with Annex II, III, V or VI, they shall specify the period of validity of the decision, which initially shall be for a period of not more than five years.3Where an approved body and a manufacturer or the manufacturer’s UK responsible person have agreed that the manufacturer may apply to the body at a specified time for an extension of the period of validity of a decision referred to in paragraph (2), the body may, on application from and with the agreement of the manufacturer or the manufacturer’s UK responsible person, extend the period of validity of the decision for further periods of up to five years, each such period commencing on the expiry of the previous period.4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Registration of persons placing general medical devices on the market
Regulation 19
191Paragraph (2) applies—ain relation to relevant devices that are neither Class I devices nor custom-made devices, to—ia manufacturer with a registered place of business in Northern Ireland who, under their own name, places on the market in Northern Ireland any general medical device of any class, other than a system or procedure pack which is not CE marked;ii. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .iiia manufacturer’s authorised representative who has a registered place of business in Northern Ireland;iva manufacturer with a registered place of business in Great Britain whose authorised representative does not have a registered place of business in Northern Ireland;bin relation to Class I devices that are not custom-made devices, to—ia manufacturer who places a device on the Northern Ireland market and has a registered place of business in Northern Ireland;iian authorised representative with a registered place of business in Northern Ireland;cto a person with a registered place of business in Northern Ireland who sterilises before use any devices designed by their manufacturer to be sterilised before use.2For the purpose of enabling the Secretary of State to exercise the Secretary of State’s functions under these Regulations, any person to whom this paragraph applies must—ainform the Secretary of State of their address and registered place of business;bsupply the Secretary of State with a description of each category of device concerned;c. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .din the case of an authorised representative, supply the Secretary of State with—iwritten evidence that they have been designated as an authorised representative;iidetails of the person who has so designated them; andiiiwhere the person placing the devices concerned on the market is neither the manufacturer nor the authorised representative, the name and address of the registered place of business of the person placing the devices concerned on the market;einform the Secretary of State of any changes to the information referred to in sub-paragraphs (a) to (d) as and when such changes arise.3The obligation in paragraph 2(2)(e) to inform the Secretary of State of any changes in relation to the information referred to in sub-paragraphs (2)(a) to (d) continues to apply following the passing of any of the dates specified in paragraph (4) that apply in respect of a particular case.4The obligations in paragraph (2) begin to apply—ain the case of a device that is a Class I device and custom-made devices, on 1st January 2021;bin the case of a device that is a Class III or IIb implantable device, on 1st May 2021;cin the case of a device that is a Class IIa or Class IIb non-implantable device, on 1st September 2021.5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Additional requirements relating to use of animal tissues
Regulation 19A
19A. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Obligations in Part II of these Regulations which are met by complying with obligations in Directive 93/42
Regulation 19B
19B1In this regulation—a“the Directive” means Directive 93/42 as it had effect on 25 May 2021 and any reference to an Article or Annex is a reference to that Article or Annex in the Directive ...;b“Regulation 722/2012” means Commission Regulation (EU) 722/2012 as it has effect in EU law;c“CE marking” means the CE marking required by Article 17 and shown in Annex XII;d“harmonised standard” is to be construed in accordance with Article 5.2Where paragraph (3) applies regulations 8, 9, 10(1) to (4), 11 and 13 are treated as being satisfied.3 Subject to paragraph (3A), this paragraph applies where, before placing a relevant device other than a system or procedure pack, a custom-made device or a device intended for clinical investigation on the market, the manufacturer—aensures—ithat the device meets the essential requirements set out in Annex I and, where applicable, Regulation 722/2012, which apply to it; oriithat paragraph (10) and (11) apply;bensures that the relevant conformity assessment procedure that applies to the device has been carried out in accordance with Article 11;baensures that any certificate issued by a notified body in connection with that conformity assessment procedure is valid by virtue of Article 120(2) of Regulation (EU) 2017/745;censures that the documentation required by the conformity assessment procedure is drawn up;densures that the technical and other relevant documentation required by the relevant conformity assessment procedure is prepared in or translated into English;eaffixes a CE marking and, where applicable, the identification number of the notified body which carried out the relevant conformity assessment on the device in accordance with the procedure set out in Annexes II, III, IV, V, VI or VII;fhas drawn up before 26 May 2021 an EU declaration of conformity in accordance with Article 11; andgensures that the declaration of conformity is prepared in or translated into English.3AParagraph (3) only applies to a class I device under the Directive if—athe conformity assessment procedure under Article 11 required the involvement of a notified body; orbthe conformity assessment procedure for that device under Article 52 of Regulation (EU) 2017/745 would require the involvement of a notified body (if it were to be assessed under that regulation).4Where paragraph (5) applies, regulations 8 and 15 are treated as being satisfied.5This paragraph applies where, before a custom-made device is placed on the market, the manufacturer—ahas drawn up a statement in English containing the information required by Section 1 and specified in Section 2.1 of Annex VIII, read with Regulation 722/2012;bhas undertaken to keep available to the Secretary of State (notwithstanding that the Secretary of State is not a competent authority) documentation allowing for an understanding of the design, manufacture and performance of the device, including the expected performances, so as to allow an assessment of conformity of the device with the requirements of the Directive;cundertakes to the Secretary of State—ito comply with Section 3.1 of Annex VIII;iito keep all documentation required by Annex VIII available in accordance with Section 4 of Annex VIII; andiiito pass the statement mentioned in subparagraph (a) on with the custom-made device so that it may be made available to the patient on request.6Where paragraph (7) applies, regulations 8 and 14 are treated as being satisfied.7This paragraph applies where before a system or procedure pack is placed on the market, the manufacturer—ahas complied with Article 12(2);bhas complied with Article 12(3) and with the procedure in Annex II or V;baensures that any certificate in relation to the system or procedure pack or a device within it that was issued by a notified body under the Directive is valid by virtue of Article 120(2) of Regulation (EU) 2017/745;bbensures that the declarations required by Article 12 were drawn up before 26 May 2021;cundertakes to keep the declarations required by Article 12 for the period specified in Article 12(4); ...densures that the system or procedure pack is accompanied by the information referred to in point 13 of Annex I which must be in English; and eensures that the system or procedure pack does not contain a class I device under the Directive for which—ithe conformity assessment procedure under Article 11 did not require the involvement of a notified body; andiithe conformity assessment procedure under Article 52 of Regulation (EU) 2017/745 would not require the involvement of a notifed body (if it were to be assessed under that regulation).8Where paragraph (9) applies, regulations 8 and 16 are treated as being satisfied.9This paragraph applies where before a relevant device intended for clinical investigation is made available in Great Britain for the purpose of a clinical investigation, the manufacturer—ahas provided the Secretary of State with the relevant written notice which must be in English in the form of the Statement required by Sections 1 and 2.2 of Annex VIII;bundertakes to keep available the documentation referred to in Section 3.2 of Annex VIII for the period specified in Section 4 of that Annex; andchas taken all necessary measures to ensure that the manufacturing process for the device produces devices in accordance with the documentation referred to in the first paragraph of paragraph 3.1 of Annex VIII.10Where paragraph (11) applies, a relevant device referred to in that paragraph is also treated as complying with the relevant essential requirement referred to in regulation 9(4).11This paragraph applies where a relevant device conforms with a harmonised standard or part of a harmonised standard, which corresponds exactly to a designated standard or part of a designated standard.12For the purpose of this regulation in regulations 10(5), 51 and 61(8), each reference to “UK marking” is to be read as a reference to “CE marking”.
Obligations in Part II and III of these Regulations which are met by complying with obligations in Regulation (EU) 2017/745
Regulation 19C
19C1In this regulation—a“the Regulation” means Regulation (EU) 2017/745, as it has effect in EU law, and any reference to an Article or an Annex is a reference to an Article or Annex of the Regulation;b“CE marking” means the CE marking required by Article 20 and presented in Annex V;c“harmonised standard” has the meaning given in Article 2(70);d“sponsor” has the meaning given in Article 2(49).2Where paragraph (3) applies, regulations 8, 10(1) to (4), 11, 13, 22, 23, 24 and 27 are treated as being satisfied.3This paragraph applies where, before placing a relevant device within the meaning of Part II or Part III (as the case may be) other than a system or procedure pack, a custom-made device or a device intended for clinical investigation on the market, the manufacturer—aensures—ithat the device meets the general safety and performance requirements in Annex I which apply to it; oriithat paragraphs (10) and (11) apply;bensures that the relevant conformity assessment procedure that applies to the device has been carried out in accordance with Article 52;baensures that any certificate issued by a notified body in connection with that conformity assessment procedure has not expired or been withdrawn;censures that the documentation required by the relevant conformity assessment procedure is drawn up;densures that the technical documentation required by Annexes II and III and other relevant documentation required by a relevant conformity assessment procedure is prepared in or translated into English;eaffixes a CE marking and, where applicable, the identification number of the notified body which carried out the relevant conformity assessment on the device in accordance with the procedure set out in Annexes IX, X or XI;fdraws up an EU declaration of conformity in accordance with Article 19;gensures that the declaration of conformity is prepared in or translated into English.4Where paragraph (5) applies regulations 8 and 15 (or as the case may be) 22 and 28 are treated as being satisfied.5This paragraph applies where, before a custom-made device is placed on the market, the manufacturer—ahas drawn up a statement in English containing the information specified in Section 1 of Annex XIII;bhas undertaken to keep available to the Secretary of State (notwithstanding that the Secretary of State is not a competent national authority) documentation allowing for an understanding of the design, manufacture and performance of the device, including the expected performances, so as to allow assessment of the conformity of the device with the requirements of the Regulation; andcundertakes to comply with Sections 3 (manufacturing), 4 (retention of information) and 5 (review of experience) of Annex XIII.6Where paragraph (7) applies, regulations 8 and 14 are treated as being satisfied.7This paragraph applies where, before a system or procedure pack is placed on the market, the person responsible for combining devices to produce that system or procedure pack—ahas complied with the relevant requirements of Article 22 including where that Article requires a conformity assessment in accordance with Annex IX or XI; andbensures that any certificate issued by a notified body in connection with that conformity assessment procedure has not expired or been withdrawn.8Where paragraph (9) applies, regulations 8 and 16(1) or (as the case may be) 22 and 29(1) are treated as being satisfied.9This paragraph applies where, before a relevant device intended for clinical investigation is made available in Great Britain for the purpose of a clinical investigation, the manufacturer—ahas provided the Secretary of State with the required notice in the form of the application required by Article 70 in English; andbhas provided the Secretary of State with an undertaking to keep available documentation contained in the application in accordance with Section 3 of Chapter III of Annex XV.10Where paragraph (11) applies, a relevant device referred to in that paragraph is also treated as complying with the relevant essential requirement referred to in regulation 9(4) or regulation 23(4) (as the case may be).11This paragraph applies where a relevant device conforms with a harmonised standard or part of a harmonised standard, which corresponds exactly to a designated standard or part of a designated standard.12For the purpose of this regulation in regulations 10(5), 51 and 61(8), each reference to “UK marking” is to be read as a reference to “CE marking”.
PART III — Active Implantable Medical Devices
Interpretation of Part III
Regulation 20
201In this Part...—“custom-made device” means an active implantable medical device that is—manufactured specifically in accordance with a medical specialist’s written prescription which gives, under his responsibility, specific characteristics as to its design; andintended to be used only for a particular patient; and“relevant device” shall be construed in accordance with regulation 21.2In this Part..., a reference to a numbered ... Annex is to the ... Annex of Directive 90/385 bearing that number.
Scope of Part III
Regulation 21
211The requirements of this Part in respect of relevant devices apply in respect of active implantable medical devices and accessories to such devices, ...2Where a hazard exists, devices which are also machinery shall also meet the essential health and safety requirements set out in Part 1 of Schedule 2 to the Supply of Machinery (Safety) Regulations 2008 to the extent to which those essential health and safety requirements are more specific than the essential requirements set out in Annex I to Directive 90/385.3Where an active implantable device is intended to administer a medicinal product, that device must be governed by this Part without prejudice to the provisions of the Human Medicines Regulations 2012.4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Registration of persons placing active implantable medical devices on the market
Regulation 21A
21A1No person may place a relevant device on the market in accordance with this Part unless that person—ais established in Great Britain; andbhas complied with paragraph (2).2A person who places a relevant device on the market complies with this paragraph if, before placing the relevant device on the market—awhere—ithat person is the manufacturer of that device and is based in Great Britain, the person informs the Secretary of State of the address of their registered place of business in Great Britain;iithat person is the manufacturer of that device and is based outside the United Kingdom, and the manufacturer appoints a sole UK responsible person, and that UK responsible person provides the Secretary of State with written evidence that they have the manufacturer’s authority to act as their UK responsible person; oriiithat person is not the manufacturer of the device, the address of that person’s registered place of business in Great Britain has been provided to the Secretary of State by the manufacturer or the UK responsible person;bthat person supplies the Secretary of State with a description of the relevant device; andcthat person pays to the Secretary of State the relevant fee in accordance with regulation 53.2AThe person responsible for providing information in accordance with paragraph (2) must inform the Secretary of State of any changes to that information.3 The UK responsible person appointed in accordance with paragraph (2)(a)(ii) must—aensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;bkeep available to the Secretary of State a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements;cin response to a request from the Secretary of State, provide the Secretary of State with all the information and documentation necessary to demonstrate the conformity of a device;d where they have samples of the device or access to the device, comply with any request from the Secretary of State to provide such samples or access; ewhere they have neither samples of the device nor access to the device, communicate to the manufacturer any request from the Secretary of State to provide such samples or access, and communicate to the Secretary of State whether the manufacturer intends to comply with that request;fcooperate with the Secretary of State on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;gimmediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been appointed;hif the manufacturer acts contrary to its obligations under these Regulations—iterminate the legal relationship with the manufacturer; andiiinform the Secretary of State and, if applicable, the relevant approved body of that termination.4 In this regulation—athe references to “technical documentation” are to be construed in accordance with Annex 2, 3 or 5;bthe references to “declaration of conformity” are to be construed in accordance with Annexes 2, 3 and 5.
Registration of persons placing active implantable medical devices on the market
Regulation 21B
21B1Paragraph (2) applies—ain relation to relevant devices other than custom-made devices, to—ia manufacturer with a registered place of business in Northern Ireland who, under their own name, places on the market in Northern Ireland any relevant device;ii. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .iiia manufacturer’s authorised representative who has a registered place of business in Northern Ireland;iva manufacturer with a registered place of business in Great Britain whose authorised representative does not have a registered place of business in Northern Ireland;b. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2For the purpose of enabling the Secretary of State to exercise the Secretary of State’s functions under these Regulations, any person to whom this paragraph applies must—ainform the Secretary of State of the address of their registered place of business; andbsupply the Secretary of State with a description of each category of device concerned;c. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .din the case of an authorised representative, supply the Secretary of State with—iwritten evidence that they have been designated as an authorised representative;iidetails of the person who has so designated them; andiiiwhere the person placing the devices concerned on the market is neither the manufacturer nor the authorised representative, the name and address of the registered place of business of the person placing the devices concerned on the market;einform the Secretary of State of any changes to the information referred to in sub-paragraphs (a) to (d) as and when such changes arise.3The obligation in paragraph 2(2)(e) to inform the Secretary of State of any changes in relation to the information referred to in sub-paragraphs (2)(a) to (d) continues to apply following the passing of the date specified in paragraph (4).4The obligations in paragraph (2) begin to apply on 1st May 2021.5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Requirement to appoint a UK responsible person for active implantable medical devices
Regulation 21C
21C. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Essential requirements for active implantable medical devices
Regulation 22
221Subject to regulation 26, no person shall place on the market or put into service a relevant device unless that device meets those essential requirements set out in Annex 1 which apply to it and the requirements set out in Regulation (EU) No 722/2012 (if applicable).2Subject to regulation 26, no person shall supply a relevant device—aif that supply is also a placing on the market or putting into service of that device; orbin circumstances where that device has also been placed on the market or put into service,unless that device meets those essential requirements set out in Annex 1 which apply to it and the requirements set out in Regulation (EU) No 722/2012 (if applicable).
Determining compliance of active implantable medical devices with relevant essential requirements
Regulation 23
231In determining which are the relevant essential requirements for a particular relevant device, and whether or not it complies with any of the relevant essential requirements, account shall be taken of its intended purpose.2Any—adetermination that a relevant device complies with any of the essential requirements set out in paragraphs 1 to 5 of Annex 1; andbevaluation of side effects or undesirable effects for the purposes of determining whether or not a relevant device complies with any of the essential requirements,shall be based in particular on clinical data, the adequacy of which is based on the collation of scientific literature or the results of clinical investigations referred to in paragraph 1 of Annex 7, and any determination as to whether or not a relevant device complies with any other essential requirements may be based on such data.3In the case of a relevant device which is being or has been put into service—athe essential requirements specified in paragraph 14 of Annex 1 are complied with only if the particulars there specified are in English (whether or not they are also in another language and whether or not the device is for professional use); andbthe essential requirements specified in paragraph 13 of Annex 1, so far as they relate to instructions required for the operation of a device in paragraph 15 of Annex 1, are complied with only if—ithe instructions are in English ...ii. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4A relevant device shall be treated as complying with an essential requirement if it conforms as respects that requirement to a relevant designated standard, unless there are reasonable grounds for suspecting that the device does not comply with that requirement.5A custom-made device in respect of which the conditions specified in Annex 6 are satisfied and which is accompanied by the statement referred to in paragraph 1 of Annex 6 shall be taken to comply with the relevant essential requirements unless there are reasonable grounds for suspecting that the device does not comply with those requirements.6A device intended for clinical investigation in respect of which—athe conditions specified in Annex 7 are satisfied;bnotice has been given under regulation 29(1); andceither—ino notice has been given under regulation 29(3) within the period of 60 days there referred to, oriinotice has been given under regulation 29(4),shall be taken to comply with the relevant essential requirements unless there are reasonable grounds for suspecting that the device does not comply with those requirements.
UK marking of active implantable medical devices
Regulation 24
241Subject to regulation 26, no person shall place on the market or put into service a relevant device unless that device or its sterile pack bears a UK marking which—ameets the requirements set out in Annex 2 of Regulation 765/2008;bis in a visible, legible and indelible form; andcis accompanied by any relevant approved body or conformity assessment body identification number for that device.2Subject to regulation 26, no person shall supply a relevant device unless that device or its sterile pack bears a UK marking which—ameets the requirements set out in Annex 2 of Regulation 765/2008;bis in a visible, legible and indelible form; andcis accompanied by any relevant approved body or conformity assessment body identification number for that device,if that supply is also a placing on the market or putting into service, or if that supply is of a device that has been placed on the market or put into service.3Subject to regulation 26, no person shall place on the market or put into service a relevant device unless a UK marking, meeting the requirements set out in Annex 2 of Regulation 765/2008, appears on—awhere appropriate, any sales packaging for that device; andbthe instructions for use for the device,and that UK marking is accompanied by any relevant approved body or conformity assessment body identification number for that device.4Subject to regulation 26, no person shall supply a relevant device (if that supply is also a placing on the market or putting into service, or if that supply is of a device that has been placed on the market or put into service) unless a UK marking, meeting the requirements set out in Annex 2 of Regulation 765/2008, appears on—awhere appropriate, any sales packaging for that device; andbthe instructions for use for the device,and that UK marking is accompanied by any relevant approved body or conformity assessment body identification number for that device.5No person shall affix any mark or inscription to, or provide any information comprising a mark or inscription on—aa relevant device or its sterile pack;bthe instructions for use for a relevant device; orcwhere appropriate, any sales packaging for a relevant device,which is likely to mislead a third party with regard to the meaning or the graphics of the UK marking or which reduces the visibility or the legibility of the UK marking.6In this regulation, where a device is required to bear a UK marking which meets the requirements of Annex 2 of Regulation (EU) No 765/2008, the requirement as to the minimum size of the UK marking specified in section 3 of that Annex is to be understood—aas not applying where, having regard to the small size of the device, it is not possible for the device to bear a marking of that minimum size; andbas allowing a device to bear a UK marking of a size less than that minimum size provided that mark continues to meet the requirements as to visibility, legibility and indelibility in paragraphs (1) and (2).
UK(NI) indication: active implantable medical devices
Regulation 24A
24A1Where the CE marking referred to in regulation 24 is affixed on the basis of an assessment or a certificate issued by a notified body established in the United Kingdom, a UK(NI) indication must be affixed in relation to the device, in accordance with this regulation.2The UK(NI) indication must be affixed—avisibly, legibly and indelibly; andbbefore a relevant medical device is placed on the market in Northern Ireland.3The UK(NI) indication must accompany the CE marking, wherever that is affixed in accordance with regulation 27.3AThe UK(NI) indication may be less than 5mm high provided that it is the same height as the CE marking that it accompanies.4The UK(NI) indication must be affixed by the manufacturer.5Anyone who places a medical device on the market in Northern Ireland must ensure that the manufacturer has complied with their obligations under this regulation.6No person shall supply a relevant device unless the manufacturer has affixed a UK(NI) indication as required by this regulation, if that supply is also a placing on the market or putting into service, or that supply is of a device that has been placed on the market or put into service”;
UK marking of active implantable medical devices that come within the scope of this Part and other legislation
Regulation 25
25Where a relevant device (within the meaning of this Part) comes within the scope of this Part and other product safety or health and safety legislation (“the other legislation”) a person must not affix a UK marking to the device unless the relevant requirements of the other legislation are also satisfied.
Exemptions from regulations 22 and 24
Regulation 26
261A relevant device being shown at a trade fair, exhibition, demonstration or similar gathering is not being placed on the market or put into service if a visible sign clearly indicates that the device or product cannot be marketed or put into service until it complies with the requirements of ... these Regulations.2Regulation 24 shall not apply to a custom-made device or a device intended for clinical investigation.3Regulations 22 and 24 shall not apply where, following a duly justified request and in the interests of the protection of health, the Secretary of State has authorised, where appropriate for a specified period, the placing on the market or putting into service of a particular relevant device or relevant devices of a particular class or description without a UK marking, where appropriate subject to conditions (which are complied with), and has not withdrawn that authorisation.4Regulations 22 and 24 do not apply where the Secretary of State directs that a relevant device, or a class of relevant devices, which meets other requirements or standards or which is marked other than with a UK marking which the Secretary of State determines is equivalent to the requirements and standards imposed by regulations 22 and 24, may be placed on the market.5In paragraph (4), the Secretary of State, in determining whether a standard or requirement or marking (“the other standard”) is equivalent to a standard or requirement imposed by regulations 22 and 24, must be satisfied that the other standard imposes a degree of safety and quality equivalent to that imposed by those regulations.
Procedures for affixing a UK marking to active implantable medical devices
Regulation 27
27A relevant device may bear a UK marking only if its manufacturer or their UK responsible person—afulfils the applicable obligations imposed by—iAnnex 2, oriiAnnex 3, together with Annex 4 or 5;bdeclares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of this Part that apply to it; ...censures that the device meets the provisions of this Part which apply to it; anddfulfils the obligations imposed by Regulation (EU) No 722/2012 (if applicable).
Procedures for custom-made active implantable medical devices
Regulation 28
28No person shall supply a custom-made device (if that supply is also a placing on the market, or if that supply is of a custom-made device that has been placed on the market) unless its manufacturer or their UK responsible person—ahas drawn up the statement containing the information required by Section 2.1 of Annex 6, read with Regulation (EU) No 722/2012;bhas undertaken to keep available for the Secretary of State the documentation referred to in Section 3.1 of Annex 6;ctakes all necessary measures to ensure that the manufacturing process ensures that each device manufactured according to that process conforms to the documentation referred to in the first paragraph of Section 3.1 of Annex 6; anddkeeps available for the Secretary of State the information contained in the statement referred to in paragraph (a) and in the undertaking referred to in paragraph (b).
Procedures for active implantable medical devices for clinical investigations
Regulation 29
291No person shall supply a relevant device (if that supply is also a making available of the device) for the purposes of a clinical investigation in Great Britain unless, before he does so, the manufacturer of the device or their UK responsible person has given at least 60 days prior notice in writing to the Secretary of State of the intended investigation, in the form of—asubject to paragraph (2), the statement required by Section 2.2 of Annex 6 , read with Regulation (EU) No 722/2012; andban undertaking to keep available for the Secretary of State the documentation referred to in Section 3.1 and 3.2 of Annex 6.1AA manufacturer or their UK responsible person may request a meeting with the Secretary of State in advance of giving notice in writing to the Secretary of State pursuant to paragraph (1) in order to—aobtain advice on regulatory requirements relating to an intended clinical investigation; orbobtain a statistical review in relation to an intended clinical investigation.2The ethics committee opinion that forms part of the information required under Section 2.2 of Annex 6 need not be provided to the Secretary of State at least 60 days prior to the intended investigation, but if it is not provided at least 60 days prior to the intended investigation, it must be provided to the Secretary of State by the manufacturer or their UK responsible person as soon as it becomes available.3If, within 60 days of the formal acceptance by the Secretary of State of the notice in writing given pursuant to paragraph (1), the Secretary of State gives written notice to the manufacturer or UK responsible person (whichever gave the notice pursuant to paragraph (1)) that, on grounds of public health or public policy, the relevant device should not be made available for the purposes of the intended investigation, no person shall supply the relevant device (if that supply is also a making available of the device) for those purposes.4The Secretary of State may, in respect of notice in writing given by a manufacturer or their UK responsible person pursuant to paragraph (1), give written notice to the manufacturer or their UK responsible person—aif the ethics committee opinion required under Section 2.2 of Annex 6 is favourable, that the relevant device may be made available for the purposes of the intended investigation; orbif the ethics committee opinion required under Section 2.2 of Annex 6 is not available, that the relevant device may be made available for the purposes of the intended investigation once a favourable opinion in respect of the investigational plan for the intended investigation has been delivered by the committee.5A written notice pursuant to paragraph (4) may—awhere appropriate be given subject to conditions imposed by the Secretary of State, which are to be included in the notice;bat any time be withdrawn on grounds of public health or public policy by the Secretary of State.6Where a written notice pursuant to paragraph (4) in respect of a relevant device has been withdrawn by the Secretary of State—afurther clinical use of the relevant device in the investigation is prohibited; andbno person shall supply that relevant device for the purposes of the investigation (if that supply is also a making available of the device),unless the Secretary of State issues a further written notice pursuant to that paragraph stating that the relevant device may again be made available for the purposes of the investigation.7The manufacturer of a relevant device intended for clinical investigation to which paragraph (1) applies, or their UK responsible person, shall—atake all necessary measures to ensure that the manufacturing process ensures that each device manufactured according to that process conforms to the documentation referred to in the first paragraph of Section 3.1, and the first paragraph of Section 3.2, of Annex 6;bkeep available for the Secretary of State the information contained in the statement and the undertaking referred to in paragraph (1); andcauthorise the assessment, including audit where necessary, of the effectiveness of the measures which he takes pursuant to this regulation.8The grounds of public health or public policy referred to in paragraphs (3) and (5)(b) are met, amongst other reasons, if—athe manufacturer or their UK responsible person does not authorise an assessment by the Secretary of State, whether by means of an audit, an inspection or otherwise, of the effectiveness of the measures referred to in paragraph (7); orbthe manufacturer or their UK responsible person does not make available to the Secretary of State documentation which he has undertaken to keep available in accordance with paragraph (1).9No person shall conduct a clinical investigation of a relevant device—aotherwise than in accordance with Annex 7; andbotherwise than in accordance with any conditions imposed by the Secretary of State pursuant to paragraph (5)(a),and if a clinical investigation is conducted in respect of a relevant device, the manufacturer of that device or their UK responsible person shall keep available for the Secretary of State the report referred to in Section 2.3.7 of Annex 7.10The manufacturer, or their single UK responsible person, shall—anotify the Secretary of State of the end of the clinical investigation; andbprovide justification where premature termination has resulted.
Manufacturers etc. and conformity assessment procedures for active implantable medical devices
Regulation 30
301A manufacturer of a relevant device or, where applicable, their UK responsible person who is required to follow, or follows or has followed a conformity assessment procedure in the Annexes referred to in regulation 27(a) shall observe the manufacturer’s obligations set out in that procedure that apply to him.2A manufacturer of a relevant device or, where applicable, their UK responsible person shall, when following a conformity assessment procedure in the Annexes referred to in regulation 27(a), take account of the results of any assessment or verification operations which have been carried out ... at an intermediate stage of manufacture of the device.3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Obligations in Part III which are met by complying with obligations in Directive 90/385
Regulation 30A
30A1In this regulation—a“the Directive” means Directive 90/385 as it had effect on 25 May 2021 and any reference to an Article or Annex is a reference to that Article or Annex in the Directive ...;b“Regulation 722/2012” means Commission Regulation (EU) 722/2012 as it has effect in EU Law;c“CE marking” means the CE marking required by Article 12 and shown in Annex 9;d“harmonised standard” is to be construed in accordance with Article 5.2Where paragraph (3) applies regulations 22, 24(1) to (4), 25 and 27 are treated as being satisfied.3This paragraph applies where, before placing a relevant device other than a system or procedure pack, a custom-made device or a device intended for clinical investigation on the market, the manufacturer—aensures—ithat the device meets the essential requirements set out in Annex I and, where applicable, Regulation (EU) 722/2012, which apply to it; oriithat paragraphs (8) and (9) apply;bensures that the relevant conformity assessment procedure that applies to the device, where the device is a device other than those which are custom-made or intended for clinical investigations, has been carried out in accordance with Article 9;baensures that the certificate issued by a notified body in connection with that conformity assessment procedure is valid by virtue of Article 120(2) of Regulation (EU) 2017/745;censures that the documentation required by the relevant conformity assessment procedure is drawn up;densures that the technical and other relevant documentation required by the relevant conformity assessment procedure is prepared in or translated into English;eaffixes a CE marking and, where applicable, the identification number of the notified body which carried out the relevant conformity assessment on the device in accordance with the procedure set out in Annexes 2, 3, 4 or 5;fhas drawn up before 26 May 2021 an EU Declaration of Conformity in accordance with Article 9; andgensures that the declaration of conformity is prepared in or translated into English.4Where paragraph (5) applies, regulations 25 and 28 are treated as being satisfied.5This paragraph applies where, before a custom-made device is placed on the market, the manufacturer—ahas drawn up a statement in English containing the information required by Section 1 and specified in Section 2.1 of Annex 6, read with Regulation 722/2012;bhas undertaken to keep available to the Secretary of State (notwithstanding that the Secretary of State is not a competent authority) documentation allowing for an understanding of the design, manufacture and performance of the device, including the expected performances, so as to allow an assessment of conformity of the device with the requirements of the Directive;cundertakes to the Secretary of State—ito comply with Section 3.1 of Annex 6;iito keep all documentation required by Annex 6 for the period specified in Section 4 of Annex 6; andiiito pass on the statement mentioned in sub-paragraph (a) with the custom-made device so that it may be made available to the patient on request.6Where paragraph (7) applies, regulations, 22 and 29 are treated as being satisfied.7This paragraph applies where, before a relevant device intended for clinical investigation is made available in Great Britain for the purpose of a clinical investigation, the manufacturer—ahas provided the Secretary of State with the relevant written notice which must be in English in the form of the statement required by Section 2.2 of Annex 6;bhas provided an undertaking to keep available for five years the documentation referred to in Section 3.1 and 3.2 of Annex 6; andchas taken all necessary measures to ensure that the manufacturing process for the device produces devices in accordance with the documentation referred to in Section 3.2 of Annex 6.8Where paragraph (9) applies, a relevant device referred to in that paragraph is also treated as complying with the relevant essential requirement referred to in regulation 9(4).9This paragraph applies where a relevant device conforms with a harmonised standard or part of a harmonised standard, which corresponds exactly to a designated standard or part of a designated standard.10For the purpose of this regulation in regulations 24(5), 51 and 61(8), each reference to “UK marking” is to be read as a reference to “CE marking”.
Approved bodies and the conformity assessment procedures for active implantable medical devices
Regulation 31
311 An approved body which is responsible for carrying out a conformity assessment procedure in relation to a relevant device shall, when carrying out the procedure—atake account of the results of any assessment or verification operations which have been carried out in accordance with this Part at an intermediate stage of manufacture of the device; andblay down, by common accord with the manufacturer or their UK responsible person, the time limits for completion of the assessment and verification operations referred to in Annex 2 or 3.2Where an approved body takes a decision in accordance with Annex 2, 3 or 5, they shall specify the period of validity of the decision, which initially shall be for a period of not more than five years.3 Where an approved body and a manufacturer or the manufacturer’s UK responsible person have agreed that the manufacturer may apply to the body at a specified time for an extension of the period of validity of a decision referred to in paragraph (2), the body may, on application from and with the agreement of the manufacturer or the manufacturer’s UK responsible person, extend the period of validity of the decision for further periods of up to five years, each such period commencing on the expiry of the previous period.
PART IV — In Vitro Diagnostic Medical Devices
Interpretation of Part IV
Regulation 32
321In this Part ...—“accessory” means an article intended specifically by its manufacturer to be used together with an in vitro diagnostic medical device to enable that device to be used in accordance with its intended purpose, which is not—itself an in vitro diagnostic medical device;an invasive sampling medical device; ora medical device which is directly applied to the human body for the purpose of obtaining a specimen;“calibration and control material” means any substance, material or article intended by its manufacturer either to establish measurement relationships or to verify the performance characteristics of a relevant device in conjunction with the intended use of that device;“common technical specification” means a technical specification set out in the Annex to Commission Decision 2002/364/EC (as retained under section 3 of the European Union Withdrawal Act 2018 and modified under section 8 of that Act) for a relevant device referred to in a list in Annex II;“device for self-testing” means anin vitro diagnostic medical device which is intended by its manufacturer to be able to be used by a member of the public in a home environment; and“relevant device” shall be construed in accordance with regulation 33(1);2In this Part ..., a reference to a numbered article or Annex is to the article or Annex of Directive 98/79 bearing that number.
Scope of Part IV
Regulation 33
331The requirements of this Part in respect of relevant devices apply in respect ofin vitro diagnostic medical devices (including coronavirus test devices) and accessories to such devices, except for—aproducts manufactured and used within the same health institution and either on the premises of their manufacture or on premises in the immediate vicinity without having been transferred to another legal entity; andbdevices that come within the scope of Directive 98/79 and another Directive (“the other Directive”) issued by one or more of the institutions of the Community, andithe other Directive includes a provision allowing the manufacturer of the device to choose, during a transitional period that has not ended, which set of arrangements applies to it, andiithe manufacturer chooses to follow the set of arrangements in the other Directive.2The requirements of this Part in respect of devices for performance evaluation do not apply in respect of—aproducts manufactured and used only within the same health institution and either on the premises of their manufacture or on premises in the immediate vicinity without having been transferred to another legal entity; andbdevices that come within the scope of Directive 98/79 and another Directive (“the other Directive”) issued by one or more of the institutions of the Community, andithe other Directive includes a provision allowing the manufacturer of the device to choose, during a transitional period that has not ended, which set of arrangements applies to it, andiithe manufacturer chooses to follow the set of arrangements in the other Directive.
Registration etc. of persons placing in vitro diagnostic medical devices on the market
Regulation 33A
33A1No person may place a relevant device on the market in accordance with this Part unless that person—ais established in Great Britain; andbhas complied with paragraph (2).2A person who places a relevant device on the market complies with this paragraph if, before placing the relevant device on the market—awhere—ithat person is the manufacturer of that device and is based in Great Britain, the person informs the Secretary of State of the address of their registered place of business in Great Britain;iithat person is the manufacturer of that device and is based outside the United Kingdom, the manufacturer appoints a sole UK responsible person, and that UK responsible person provides the Secretary of State with written evidence that they have the manufacturer’s authority to act as their UK responsible person; oriiithat person is not the manufacturer of the device, the address of that person’s registered place of business in Great Britain has been provided to the Secretary of State by the manufacturer or the UK responsible person;bthat person supplies the Secretary of State with—ia description of the relevant device; andiithe relevant information in paragraph (4); andcthat person pays to the Secretary of State the relevant fee in accordance with regulation 53.2AThe person responsible for providing information in accordance with paragraph (2) must inform the Secretary of State of any changes to that information.3 The UK responsible person appointed in accordance with paragraph (2)(a)(ii) must—aensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;bkeep available for inspection by the Secretary of State a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements;cin response to a request from the Secretary of State, provide the Secretary of State with all the information and documentation necessary to demonstrate the conformity of a device;d where they have samples of the device or access to the device, comply with any request from the Secretary of State to provide such samples or access; ewhere they have neither samples of the device nor access to the device, communicate to the manufacturer any request from the Secretary of State to provide such samples or access, and communicate to the Secretary of State whether the manufacturer intends to comply with that request;fcooperate with the Secretary of State on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;gimmediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been appointed;hif the manufacturer acts contrary to its obligations under these Regulations—iterminate the legal relationship with the manufacturer; andiiinform the Secretary of State and, if applicable, the relevant approved body of that termination.4In this regulation “relevant information” means—ain relation to a new relevant device, a statement indicating that the device is a new relevant device;bif the device consists wholly or partly of reagents, reagent products or calibration and control materials, appropriate information in terms of common technological characteristics and analytes;cif the device does not wholly or partly consist of reagents, reagent products or calibration and control materials, the appropriate indications;din relation to devices in a list in Annex II and devices for self-testing—iall data allowing for identification of such devices, the analytical and, where appropriate, diagnostic parameters as referred to in Section 3 of Part A of Annex 1;iiif requested by the Secretary of State, the labelling and instructions for use for when the device is placed on the market or put into service;ein relation to devices for performance evaluation which relate either to devices referred to in a list in Annex II or to devices for self-testing, all data allowing for identification of such devices, the analytical and where appropriate, diagnostic parameters as referred to in Section 3 of Part A of Annex I.5Within two years of the placing of a new relevant device on the market, the Secretary of State may, where the Secretary of State considers it justified, request a report relating to the experience gained with the device subsequent to it being placed on the market.6In this regulation a device is a “new relevant device” if—athere has been no such device continuously available on the United Kingdom or EEA market during the previous three years for the relevant analyte or other parameter; orbuse of the device has involved analytical technology not continuously used in connection with a given analyte or other parameter on the United Kingdom or EEA market during the previous three years.7 In paragraph (3)—athe references to “technical documentation” are to be construed in accordance with Annexes III to VIII;bthe references to “declaration of conformity” are to be construed in accordance with Annexes III, IV, V and VII.
Essential requirements for in vitro diagnostic medical devices
Regulation 34
341Subject to regulation 39, no person shall place on the market or put into service a relevant device unless that device meets those essential requirements set out in Annex I which apply to it.2Subject to regulation 39, no person shall supply a relevant device—aif that supply is also a placing on the market or putting into service of that device; orbin circumstances where that device has been placed on the market or put into service, unless that device meets those essential requirements set out in Annex I which apply to it.
Approval requirement for coronavirus test devices
Regulation 34A
34A1Subject to regulations 34B to 34D, 39(1) and 39A, no person other than the Secretary of State may place on the market or put into service a coronavirus test device, unless—athe Secretary of State has approved it in accordance with regulation 38A(5); andbthe approval remains valid in accordance with regulation 38A(6).2Subject to regulations 34B to 34D, 39(1) and 39A, no person other than the Secretary of State may supply a coronavirus test device—aif that supply is also a placing on the market or putting into service of that device; orbin circumstances where that device has been placed on the market or put into service,unless the Secretary of State has approved it in accordance with regulation 38A(5) and the approval remains valid in accordance with regulation 38A(6).3The requirements in paragraphs (1) and (2) are without prejudice to the other requirements of this Part.
Public sector use of coronavirus test devices
Regulation 34B
34B1Regulation 34A(1) does not apply in relation to a coronavirus test device that is placed on the market or put into service only for use by—athe Secretary of State;ba devolved public health body; orca health service body supplied pursuant to an existing contract.2Regulation 34A(2) does not apply in relation to a coronavirus test device that is supplied to—athe Secretary of State;ba devolved public health body; orca health service body pursuant to an existing contract.3In this regulation—“a devolved public health body” is—in Wales, Welsh Ministers or Public Health Wales National Health Service Trust;in Scotland, Scottish Ministers;in Northern Ireland, the Department of Health in Northern Ireland;“an existing contract” is a contract entered into before the coming into force of regulation 34A;“a health service body” is—an NHS body as defined in section 275 of the National Health Service Act 2006 or in section 206 of the National Health Service (Wales) Act 2006;a body listed in section 17A(2)(a) to (c) or (e) of the National Health Service (Scotland) Act 1978; ora health and social care body as defined in section 1(5)(a) to (e) of the Health and Social Care (Reform) Act (Northern Ireland) 2009.
Transitional provisions for coronavirus test devices
Regulation 34C
34C1The requirements in regulation 34A do not apply in respect of any period before 1st September 2021.2A person may place on the market, put into service or supply a coronavirus test device from 1st September 2021 until the end of 31st October 2021 if—athat person has made an application to the Secretary of State in respect of that device, in accordance with regulation 38A; orbthat person is not—ithe manufacturer of the device,iia person acting as the manufacturer’s UK responsible person appointed for the purposes of regulation 33A or under regulation 44A, oriiia person acting as the manufacturer’s authorised representative in Northern Ireland in accordance with regulation 44.
Exemption for coronavirus test devices in conformity with Regulation (EU) 2017/746 and Regulation (EU) 2022/1107
Regulation 34D
34DRegulation 34A does not apply in Northern Ireland—ain relation to a coronavirus test device that is in conformity with Regulation (EU) 2017/746 and the common specifications set out in Annex I and XIII to Regulation (EU) 2022/1107;bafter 24 July 2024, in relation to a coronavirus test device that is in conformity with Regulation (EU) 2017/746.
Determining compliance of in vitro diagnostic medical devices with relevant essential requirements
Regulation 35
351In determining which are the relevant essential requirements for a particular relevant device, and whether or not it complies with any of the relevant essential requirements, account shall be taken of its intended purpose.2In order to meet the essential requirements set out in Section 8 of Part B of Annex I, the information to be provided under that Section must be in English ... .3A relevant device shall be presumed to comply with an essential requirement if it conforms as respects that requirement to a relevant designated standard.4A relevant device shall be treated as complying with an essential requirement in respect of which there is an applicable common technical specification only if it is in conformity with that specification or, if for duly justified reasons the manufacturer has not complied with that specification, an equivalent or higher specification.
UK marking of in vitro diagnostic medical devices
Regulation 36
361Subject to regulation 39, no person shall place on the market or put into service a relevant device unless, where practical and appropriate, that device bears a UK marking which—ameets the requirements set out in Annex 2 of Regulation 765/2008;bis in a visible, legible and indelible form; andcis accompanied by any relevant approved body or conformity assessment body identification number for that device.2Subject to regulation 39, no person shall supply a relevant device unless, where practical and appropriate, that device bears a UK marking which—ameets the requirements set out in Annex 2 of Regulation 765/2008;bis in a visible, legible and indelible form; andcis accompanied by any relevant approved body or conformity assessment body identification number for that device,if that supply is also a placing on the market or putting into service or if that supply is of a device that has been placed on the market or put into service.3Subject to regulation 39, no person shall place on the market or put into service a relevant device unless a UK marking, meeting the requirements set out in Annex 2 of Regulation 765/2008, appears on—aany sales packaging for that device; andbthe instructions for use for that device,and that UK marking is accompanied by any relevant approved body or conformity assessment body identification number for that device.4Subject to regulation 39, no person shall supply a relevant device (if that supply is also a placing on the market or putting into service, or if that supply is of a device that has been placed on the market or put into service) unless a UK marking, meeting the requirements set out in Annex 2 of Regulation 765/2008, appears on—aany sales packaging for that device; andbthe instructions for use for that device,and that UK marking is accompanied by any relevant approved body or conformity assessment body identification number for that device.5Subject to regulation 39, no person shall affix any mark or inscription to, or provide any information comprising a mark or inscription on—aa relevant device;bthe instructions for use for a relevant device; orcany sales packaging for a relevant device,which is likely to mislead a third party with regard to the meaning or the graphics of the UK marking or which reduces the visibility or the legibility of the UK marking.6In this regulation, where a device is required to bear a UK marking which meets the requirements of Annex 2 of Regulation (EU) No 765/2008, the requirement as to the minimum size of the UK marking specified in section 3 of that Annex is to be understood—aas not applying where, having regard to the small size of the device, it is not possible for the device to bear a marking of that minimum size; andbas allowing a device to bear a UK marking of a size less than that minimum size provided that mark continues to meet the requirements as to visibility, legibility and indelibility in paragraphs (1) and (2).
UK(NI) indication: in vitro diagnostic medical devices
Regulation 36A
36A1Where the CE marking referred to in regulation 36 is affixed on the basis of an assessment or a certificate issued by a notified body established in the United Kingdom, a UK(NI) indication must be affixed in relation to the device, in accordance with this regulation.2The UK(NI) indication must be affixed—avisibly, legibly and indelibly; andbbefore a relevant medical device is placed on the market in Northern Ireland.3The UK(NI) indication must accompany the CE marking, wherever that is affixed in accordance with regulation 36.3AThe UK(NI) indication may be less than 5mm high provided that it is the same height as the CE marking that it accompanies.4The UK(NI) indication must be affixed by the manufacturer.5Anyone who places a medical device on the market in Northern Ireland must ensure that the manufacturer has complied with their obligations under this regulation.6No person shall supply a relevant device unless the manufacturer has affixed a UK(NI) indication as required by this regulation, if that supply is also a placing on the market or putting into service, or that supply is of a device that has been placed on the market or put into service.
UK marking of in vitro diagnostic devices that come within the scope of this Part and other legislation
Regulation 37
37Where a relevant device (within the meaning of this Part) comes within the scope of this Part and other product safety or health and safety legislation (“the other legislation”) a person must not affix a UK marking to the device unless the relevant requirements of the other legislation are also satisfied.
In vitro diagnostic medical devices not ready for use
Regulation 38
38Subject to regulation 39, no person shall—aput into service a relevant device;bsupply a relevant device—iif that supply is also a putting into service of that device, oriiin circumstances where that device has been placed on the market or put into service,which is not ready for use.
Applications for approval of coronavirus test devices
Regulation 38A
38A1A person may make an application to the Secretary of State under this regulation for approval of a coronavirus test device.2An application must include such information as the Secretary of State may require for the purposes of exercising their functions under—aparagraph (5); andbregulation 38C.3An application must be made through the gov.uk website.4The Secretary of State may treat an application made before the coming into force of this regulation as an application made under this regulation, if it meets the requirements of paragraph (2).5The Secretary of State must approve a coronavirus test device if the Secretary of State is satisfied on the basis of the information contained in the application that the coronavirus test device meets the requirements of regulation 38B.6An approval granted under paragraph (5) is valid for a period of 5 years, beginning with the day on which it is granted.7Nothing in this regulation shall be taken to prevent—athe Secretary of State;ba weights and measures authority in Great Britain; orca district council in Northern Ireland,from exercising a duty under regulation 61 to enforce these Regulations.
Performance requirements for coronavirus test devices
Regulation 38B
38B1The requirements that a coronavirus test device must meet for the purposes of regulation 38A(5) are set out in paragraphs (2) to (6).2A coronavirus test device must be able to be put into service in accordance with this Part.3A coronavirus test device that is an antigen test must have—aa level of sensitivity, using a 95% two-sided confidence interval, that is entirely above 60%;ba level of specificity, using a 95% two-sided confidence interval, that is entirely above 93%.4A coronavirus test device that is a direct molecular test must have—aa level of sensitivity, using a 95% two-sided confidence interval, that is entirely above 70%;ba level of specificity, using a 95% two-sided confidence interval, that is entirely above 93%.5A coronavirus test device that is an extracted molecular test must have—aa level of sensitivity, using a 95% two-sided confidence interval, that is entirely above 93%;ba level of specificity, using a 95% two-sided confidence interval, that is entirely above 97%.6Where a coronavirus test device is also intended to detect the presence of anything other than a viral antigen or viral ribonucleic acid (RNA) specific to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the requirements in paragraphs (2) to (5) apply only in relation to its performance in detecting the presence of that viral antigen or viral ribonucleic acid (RNA).7In this regulation and in regulation 38C—“antigen test” means an in vitro diagnostic medical device for the detection of the presence of a viral antigen specific to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2);“direct molecular test” means an in vitro diagnostic medical device which—is for the detection of the presence of viral ribonucleic acid (RNA) specific to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), anddoes not use a preliminary step of purification and concentration;“extracted molecular test” means an in vitro diagnostic medical device which—is for the detection of the presence of viral ribonucleic acid (RNA) specific to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), anduses a preliminary step of purification and concentration;“sensitivity”, in relation to a coronavirus test device, means the proportion of true positives that are correctly identified by the test, calculated using the equation—Sensitivity=True PositivesTrue Positives+False Negatives“specificity”, in relation to a coronavirus test device, means the proportion of true negatives that are correctly identified by the test, calculated using the equation—Specificity=True NegativesTrue Negatives+False Positives
Register of approved coronavirus test devices
Regulation 38C
38C1The Secretary of State must establish a register of coronavirus test devices which the Secretary of State has approved in accordance with regulation 38A.2The Secretary of State must publish the register on the gov.uk website.3The register must contain the following information in respect of each coronavirus test device—athe name and address of the registered place of business of the person who made the application under regulation 38A;bif the person who made the application was not the manufacturer, the name and address of the registered place of business of the manufacturer;cthe country in which the manufacturer is established;dthe name and address of the registered place of business of the UK responsible person or the manufacturer’s authorised representative having a registered place of business in Northern Ireland, if there is one in respect of the device;ethe name and description of the coronavirus test device;fthe date and version number of the instructions for use included in the application;gwhether the coronavirus test device is an antigen test, a direct molecular test, or an extracted molecular test;hthe date on which the coronavirus test device was approved in accordance with regulation 38A and the date on which that approval ceases to be valid.4The register may contain such other information relating to the coronavirus test device and its intended use as the Secretary of State considers appropriate.
Exemptions from this Part
Regulation 39
391A relevant device being shown at a trade fair, exhibition, scientific gathering or technical gathering is not being placed on the market or put into service if—athe device is not used on any specimen taken from the participants; andba visible sign clearly indicates that the device cannot be marketed or put into service until it complies with the requirements of ... these Regulations.2Regulations 34, 36 and 38 shall not apply where, following a duly justified request and in the interests of the protection of health, the Secretary of State has authorised, where appropriate for a specified period, the placing on the market or putting into service of a particular relevant device or relevant devices of a particular class or description without a UK marking, where appropriate subject to conditions (which are complied with), and has not withdrawn that authorisation.3Regulations 34 and 36 do not apply where the Secretary of State directs that a relevant device, or a class of relevant devices, which meets other requirements or standards or which is marked other than with a UK marking which the Secretary of State determines is equivalent to the requirements and standards imposed by regulations 34 and 36, may be placed on the market.4In paragraph (3), the Secretary of State, in determining whether a standard or requirement or marking (“the other standard”) is equivalent to a standard or requirement imposed by regulations 34 and 36, must be satisfied that the other standard imposes a degree of safety and quality equivalent to that imposed by those regulations.
Exemptions for coronavirus test devices
Regulation 39A
39A1Regulation 34A does not apply where, in circumstances which give rise to a need to protect the public from a risk of serious harm to health, the Secretary of State—ahas decided to permit, where appropriate for a specified period, the placing on the market or putting into service of a particular coronavirus test device or coronavirus test devices of a particular class or description that has not been approved under regulation 38A(5); andbhas not withdrawn that permission.2The Secretary of State may give permission under paragraph (1) subject to such conditions as are set out in a protocol published by the Secretary of State.3If the Secretary of State publishes a protocol for the purpose of paragraph (2), the protocol must specify the period of time for which it has effect.4The Secretary of State may withdraw or amend a protocol published under paragraph (2).
Procedures for affixing a UK marking to in vitro diagnostic medical devices
Regulation 40
401A relevant device other than a device referred to in the lists in Annex II or a device for self-testing may bear a UK marking only if its manufacturer or their UK responsible person—afulfils the applicable obligations imposed by Sections 1 to 5 of Annex III;bdeclares, in accordance with the declaration of conformity procedure set out in that Annex, that the device meets the provisions of this Part which apply to it; andcensures that the device meets the provisions of this Part which apply to it.2A relevant device which is a device for self-testing but which is not referred to in a list in Annex II may bear a UK marking only if its manufacturer or their UK responsible person—afulfils the applicable obligations imposed by—iSections 1 to 6 of Annex III,iiAnnex IV, oriiiAnnex V and either Annex VI or Annex VII;bdeclares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of this Part which apply to it; andcensures that the device meets the provisions of this Part which apply to it.3A relevant device referred to in List A in Annex II may bear a UK marking only if its manufacturer or their UK responsible person—afulfils the applicable obligations imposed by—iAnnex IV, oriiAnnexes V and VII;bdeclares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of this Part which apply to it; andcensures that the device meets the provisions of this Part which apply to it.4A relevant device referred to in List B in Annex II may bear a UK marking only if its manufacturer or their UK responsible person—afulfils the applicable obligations imposed by—iAnnex IV,iiAnnexes V and VI, oriiiAnnexes V and VII;bdeclares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of this Part which apply to it; andcensures that the device meets the provisions of this Part which apply to it.
Manufacturers etc. and conformity assessment procedures for in vitro diagnostic medical devices
Regulation 41
411A manufacturer of a relevant device or, where applicable, their UK responsible person who is required to follow, or follows or has followed a conformity assessment procedure set out in this Part shall observe the manufacturer’s obligations set out in that procedure that apply to the manufacturer or, as the case may be, their UK responsible person.2A manufacturer of a relevant device or, where applicable, their UK responsible person shall, when following a conformity assessment procedure, take account of the results of any assessment or verification operations which have been carried out in accordance with this Part at an intermediate stage of manufacture of the device.3A manufacturer or, where applicable, their UK responsible person shall, in respect of any relevant device which the manufacturer has placed on the market or put into service, keep available for inspection by the Secretary of State—athe declaration of conformity for that device;bthe technical documentation referred to in Annexes III to VIII relating to that device; andcthe decisions, reports and certificates of approved bodies relating to that device,for a period ending five years after the manufacture of the last product.4A person who in the course of manufacturing relevant devices or devices for performance evaluation removes, collects, or uses tissues, cells or substances of human origin shall, in the course of removing, collecting or using those tissues, cells or substances act in accordance with the principles laid down in the Convention of the Council of Europe for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine .5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Approved bodies and the conformity assessment procedures for in vitro diagnostic medical devices
Regulation 42
421An approved body which is responsible for carrying out a conformity assessment procedure in relation to a relevant device shall, when carrying out the procedure—atake account of the results of any assessment or verification operations which have been carried out ... at an intermediate stage of manufacture of the device;btake account of any relevant information relating to the characteristics and performance of that device, ...; andclay down, by common accord with the manufacturer or their UK responsible person, the time limits for completion of the assessment and verification operations referred to in Annexes III to VII.2Where an approved body takes a decision in accordance with Annex III, IV, or V, they shall specify the period of validity of the decision, which, initially, shall be a period of not more than 5 years.3Where an approved body and a manufacturer or their UK responsible person have agreed that the manufacturer may apply to the body at a specified time for an extension of the period of validity of a decision referred to in paragraph (2), the body may, on application from and with the agreement of the manufacturer or their UK responsible person, extend the period of validity of the decision for further periods of up to 5 years, each such period commencing on the expiry of the previous period.
Devices for performance evaluation
Regulation 43
43No person shall supply a device for performance evaluation (if that supply is also a making available of the device) unless the manufacturer or their UK responsible person—ahas drawn up a statement containing the information required by Section 2 of Annex VIII and keeps that statement available for the Secretary of State for a minimum period of five years after the end of the performance evaluation;bensures that—ithe device conforms with the documentation mentioned in the said section 2, andiithe relevant requirements of these Regulations are complied with as respects that device; andcundertakes to keep available, and keeps available, for the Secretary of State, for a minimum period of five years after the end of the performance evaluation, documentation allowing an understanding of the design, manufacture and performances of the device, including the expected performances, so as to allow assessment of conformity of the device with the requirements of these Regulations.
Registration of persons placing in vitro diagnostic medical devices on the market or for performance evaluation
Regulation 44
441Paragraph (2) applies—ain relation to relevant devices that are Annex II devices or devices for self-testing, to—ia manufacturer with a registered place of business in Northern Ireland who, under their own name, places on the market in Northern Ireland, or makes available for performance evaluation, any relevant device;ii. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .iiia manufacturer’s authorised representative who has a registered place of business in Northern Ireland;iva manufacturer with a registered place of business in Great Britain whose authorised representative does not have a registered place of business in Northern Ireland;bin relation to relevant devices other than Annex II devices or devices for self-testing, to—ia manufacturer who places a device on the Northern Ireland market, or makes such a device available for performance evaluation, and has a registered place of business in Northern Ireland;iian authorised representative with a registered place of business in Northern Ireland.2For the purpose of enabling the Secretary of State to exercise the Secretary of State’s functions under these Regulations, any person to whom this paragraph applies must—ainform the Secretary of State of the address of their registered place of business; andbsupply the Secretary of State with—ia description of each category of device concerned;iithe relevant information in paragraph (7);c. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .din the case of an authorised representative, supply the Secretary of State with—iwritten evidence that they have been designated as an authorised representative;iidetails of the person who has so designated them; andiiiwhere the person placing the devices concerned on the market, or making them available for performance evaluation, is neither the manufacturer nor the authorised representative, the name and address of the registered place of business of the person placing the devices concerned on the market, or making them available for performance evaluation;einform the Secretary of State of any changes to the information referred to in sub-paragraphs (a) to (d) as and when such changes arise.3The obligation in paragraph 2(2)(e) to inform the Secretary of State of any changes in relation to the information referred to in sub-paragraphs (2)(a) to (d) continues to apply following the passing of any of the dates specified in paragraph (4) that apply in respect of a particular case.4The obligations in paragraph (2) begin to apply—awhere a device is being placed on the market by a manufacturer with a registered place of business in Northern Ireland or by a person who has designated an authorised representative with a registered place of business in Northern Ireland, on 1st January 2021;bin circumstances other than those described in sub-paragraph (a)—iin the case of a relevant device that is a List A device, on 1st May 2021;iiin the case of a relevant device that is a device for self-testing, on 1st September 2021; andiiiin the case of a relevant device that is a List B device, on 1st September 2021.5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7In this regulation “relevant information” means—ain relation to a new relevant device, a statement indicating that the device is a new relevant device;bif the device consists wholly or partly of reagents, reagent products or calibration and control materials, appropriate information in terms of common technological characteristics and analytes;cif the device does not wholly or partly consist of reagents, reagent products or calibration and control materials, the appropriate indications;din relation to devices in a list in Annex II and devices for self-testing—iall data allowing for identification of such devices, the analytical and, where appropriate, diagnostic parameters as referred to in Section 3 of Part A of Annex 1;iiif requested by the Secretary of State, the labelling and instructions for use for when the device is placed on the market or put into service;ein relation to devices for performance evaluation which relate either to devices referred to in a list in Annex II or to devices for self-testing, all data allowing for identification of such devices, the analytical and where appropriate, diagnostic parameters as referred to in Section 3 of Part A of Annex I.8Within two years of the placing of a new relevant device on the market, the Secretary of State may, where the Secretary of State considers it justified, request a report relating to the experience gained with the device subsequent to it being placed on the market.9In paragraphs (7) and (8) a device is a “new relevant device” if—athere has been no such device continuously available on the United Kingdom or EEA market during the previous three years for the relevant analyte or other parameter; orbuse of the device has involved analytical technology not continuously used in connection with a given analyte or other parameter on the United Kingdom or EEA market during the previous three years.
Obligations in Part IV which are met by complying with obligations in Directive 98/79
Regulation 44ZA
44ZA1In this regulation—aany reference to an Article or Annex is a reference to that Article or Annex in Directive 98/79 as it had effect on 25 May 2022;b“Regulation 722/2012” means Commission Regulation (EU) 722/2012 as it applies in the European Union;c“CE marking” means the CE marking required by Article 16 and shown in Annex X;d“harmonised standard” is to be construed in accordance with Article 5.2Where paragraph (3) applies regulations 34, 36(1) to (4), 37 and 40 are treated as being satisfied.3 Subject to to paragraph (3A), this paragraph applies where, before placing a relevant device on the market, the manufacturer—aensures—ithat the device meets the essential requirements set out in Annex I and, where applicable, Regulation (EU) 722/2012, which apply to it; oriithat paragraphs (6) and (7) apply;bensures that the relevant conformity assessment procedure that applies to the device has been carried out in accordance with Article 9;baensures that any certificate issued by a notified body in connection with that conformity assessment procedure is valid by virtue of Article 110(2) of Regulation (EU) 2017/746;censures that the documentation required by the relevant conformity assessment procedure is drawn up;densures that the technical and other relevant documentation required by a relevant conformity assessment procedure is prepared in or translated into English;eaffixes a CE marking and, where applicable, the identification number of the notified body which carried out the relevant conformity assessment on the device in accordance with the procedure set out in Annexes III, IV, V, VI or VII;f has drawn up before 26 May 2022 an EU Declaration of Conformity in accordance with Article 9;gensures that the declaration of conformity is prepared in or translated into English.3AParagraph (3) only applies to a relevant device for which the conformity assessment procedure under Article 9 did not require the involvement of a notified body, if the conformity assessment procedure for that device under Article 48 of Regulation (EU) 2017/746 would require the involvement of a notified body.4Where paragraph (5) applies, regulation 43 is treated as being satisfied.5This paragraph applies where before a relevant device intended for performance evaluation is made available in Great Britain for the purpose of a performance evaluation, the manufacturer—ahas supplied the relevant written notice which must be in English in the form required by Sections 1 and 2 of Annex VIII;bhas provided an undertaking to the Secretary of State to keep available the documentation required by Annex VIII for the period specified in Section 3 of Annex VIII;chas taken all necessary measures to ensure that the manufacturing process for the device produces devices in accordance with the documentation referred to in the first paragraph of Section 3 of Annex VIII.6Where paragraph (7) applies, a relevant device referred to in that paragraph is also treated as complying with the relevant essential requirements referred to in regulation 35(3) and (4).7This paragraph applies where—aa relevant device conforms with a harmonised standard or part of a harmonised standard, which corresponds exactly to a designated standard or part of a designated standard; orba relevant device is in conformity with a common technical specification.8For the purpose of this regulation in regulations 36(5), 51 and 61(8), each reference to “UK marking” is to be read as a reference to “CE marking”.
Obligations in Part IV of these Regulations which are met by complying with obligations in Regulation (EU) 2017/746
Regulation 44ZB
44ZB1In this regulation—aany reference to an Article or Annex is a reference to that Article or Annex in Regulation (EU) 2017/746 as it has effect in EU law;b“CE marking” means the CE marking required by Article 18 and presented in Annex V;c“harmonised standard” has the meaning given in Article 2(73);d“sponsor” has the meaning given in Article 2(57).2Where paragraph (3) applies, regulations 34, 36(1) to (4), 37 and 40 are treated as being satisfied.3This paragraph applies where, before placing a relevant device on the market, the manufacturer—aensures—ithat the device meets the general safety and performance requirements in Annex I which apply to it; oriithat paragraphs (6) and (7) apply;bensures that the relevant conformity assessment procedure that applies to the device has been carried out in accordance with Article 48;baensures that any certificate issued by a notified body in connection with that conformity assessment procedure has not expired or been withdrawn;censures that the documentation required by the relevant conformity assessment procedure is drawn up;densures that the technical documentation required by Annexes II and III and other relevant documentation required by the relevant conformity assessment procedure is prepared in or translated into English;eaffixes a CE marking and, where applicable, the identification number of the notified body which carried out the relevant conformity assessment on the device in accordance with the procedures set out in Annexes IX, X and XI;fdraws up an EU declaration of conformity in accordance with Article 17; andgensures that the declaration of conformity is prepared in or translated into English.4Where paragraph (5) applies, regulation 43 is treated as being satisfied.5This paragraph applies where, before a person supplies or makes available a device falling within Part IV for the purposes of performance evaluation, the sponsor of the performance evaluation—ahas been able to provide the Secretary of State with the required notice in the form of the application required by Chapter I of Annex XIV in English;bhas been able to provide the Secretary of State with an undertaking to keep available information contained in the application in accordance with Chapter II of Annex XIV.6Where paragraph (7) applies, a relevant device referred to in that paragraph is also treated as complying with the relevant essential requirements referred to in regulation 35(3) and (4).7This paragraph applies where—aa relevant device conforms with a harmonised standard or part of a harmonised standard, which corresponds exactly to a designated standard or part of a designated standard; orba relevant device is in conformity with a common technical specification.8For the purpose of this regulation, in regulations 36(5), 51 and 61(8), each reference to “UK marking” is to be read as a reference to “CE marking”.
PART 4A — Post-market surveillance requirements
Interpretation of Part 4A
Regulation 44ZC
44ZCIn this Part—“corrective action” means action taken in order to—eliminate the cause of a potential or actual non-conformity of a device, orreduce any other risk posed by a device,that has already been manufactured and may include recalling the device, withdrawing it from the market, and taking it out of service;“field safety corrective action” means a corrective action taken by the manufacturer to prevent or reduce the risk of a serious incident in relation to a device which has already been placed on the market or put into service;“incident” means in relation to a device that has been placed on the market or put into service—a malfunction or deterioration in the characteristics or performance of the device when used in accordance with the instructions for use,a side-effect that has a negative impact on—the health of an individual,patient management, orpublic health,an inadequacy in the design of the device, including an ergonomic feature, to enable the user to use the device safely and as intended by the manufacturer,an inadequacy in the information supplied with the device by the manufacturer to enable the user to use the device safely and as intended by the manufacturer, oran erroneous result provided by a diagnostic medical device, which informs a decision in relation to medical treatment;“lifetime of a device” means the shelf life of a device (if there is one) plus the period that the manufacturer expects that device to perform as intended;“PMS period” means the period—beginning with the day on which the first device of a device model is put into service by the manufacturer or placed on the market, whichever is sooner, andending with the end of the lifetime of the last device of that device model that is put into service by the manufacturer or placed on the market, whichever is later;“post-market surveillance” means activities carried out by manufacturers to proactively collect and review experience gained from devices placed on the market or put into service for the purposes of identifying any need to apply corrective or preventive actions;“preventive action” means action taken by the manufacturer before completion of the manufacturing phase in order to eliminate the cause of a potential non-conformity or reduce a potential risk that could be posed by the finished device;“Regulation (EU) No 722/2012” means Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin, as it had effect in the EU on 25 May 2021;“relevant device” means a device that is a “relevant device” for the purposes of Part 2, 3 or 4;“relevant essential requirements” means—in relation to a device placed on the market in accordance with regulation 19B, the essential requirements set out in Annex I of Directive 93/42 and, where applicable, Regulation (EU) No 722/2012 which apply to it;in relation to a device placed on the market in accordance with regulation 19C, the general safety and performance requirements set out in Annex I of Regulation (EU) 2017/745 which apply to it;in relation to a device otherwise placed on the market or put into service in accordance with Part 2, the requirements referred to in regulation 8 (essential requirements for general medical devices) which apply to it;in relation to a device placed on the market in accordance with regulation 30A, the essential requirements set out in Annex I of Directive 90/385 and, where applicable, Regulation (EU) No 722/2012 which apply to it;in relation to a device otherwise placed on the market or put into service in accordance with Part 3, the requirements referred to in regulation 22 (essential requirements for active implantable medical devices) which apply to it;in relation to a device placed on the market in accordance with regulation 44ZA, the essential requirements set out in Annex I of Directive 98/79 which apply to it;in relation to a device placed on the market in accordance with regulation 44ZB, the general safety and performance requirements set out in Annex I of Regulation (EU) 2017/746 which apply to it;in relation to a device otherwise placed on the market or put into service in accordance with Part 4, the essential requirements referred to in regulation 34 (essential requirements for in vitro diagnostic medical devices) which apply to it;“required risk analysis” means the analysis required to weigh the risks posed by a device against the intended performance and benefits for the purposes of confirming conformity with the relevant essential requirements;“serious deterioration of any person’s state of health” means any of the following—life-threatening illness or injury;permanent impairment of a body structure or a body function;hospitalisation or prolongation of hospitalisation;medical treatment, including surgical intervention and self-administered treatment, that is required to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function;chronic disease;foetal distress, foetal death or a congenital physical or mental impairment or birth defect;“serious incident” means an incident that directly or indirectly led, might have led or might lead to any of the following—the death of any person;the serious deterioration of any person’s state of health;a serious public health threat;“serious public health threat” means an event which could result in a risk—of death, serious illness, or serious deterioration of any person’s state of health,that affects a significant population, andthat requires prompt remedial action;“similar device” means a device which—has the same or a similar intended purpose, andis based on the same or similar technology;“system or procedure pack” has the same meaning as in regulation 5(1).
Scope of Part 4A
Regulation 44ZD
44ZD1Subject to paragraphs (2) and (3), the requirements of this Part apply in respect of relevant devices that are—aput into service by the manufacturer, orbplaced on the market,in accordance with Parts 2, 3 or 4 on or after the date on which the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 come into force.2The following regulations in this Part apply in respect of custom-made devices—aregulation 44ZC (interpretation of Part 4A);bregulation 44ZE (post-market surveillance system);cregulation 44ZF (post-market surveillance plan) except paragraphs (3)(g) and (h);dregulation 44ZG (preventive and corrective actions);eregulation 44ZH (initial reporting of serious incidents);fregulation 44ZI (investigation and final reporting of serious incidents);gregulation 44ZJ (field safety corrective actions and field safety notices);hregulation 44ZO (reports received by the Secretary of State);iregulation 44ZP (analysis of information received under Part 4A);jregulation 44ZQ (retention of post-market surveillance documentation);kregulation 44ZR (requests for post-market surveillance documentation).3This Part does not apply to—adevices intended for clinical investigation or performance evaluation;bdevices placed on the market or put into service in accordance with an authorisation issued by the Secretary of State under regulation 12(5), 26(3) or 39(2).4In this Part, the relevant devices to which this Part applies are referred to as “devices”.5In this regulation, “custom-made device” means a device within the meaning of that term as defined in regulation 5 or regulation 20.
Post-market surveillance system
Regulation 44ZE
44ZE1The manufacturer must maintain a post-market surveillance system (“PMS system”) for each device that is placed on the market or put into service.2The manufacturer must ensure the PMS system—ais proportionate to the risk posed by the device;bis appropriate to the type of device;cincludes the analysis of data relevant to the quality, performance and safety of the device throughout its lifetime, and a record of the manufacturer’s conclusions based on that analysis.3The manufacturer must ensure that the PMS system is used throughout the PMS period to identify—apreventive actions and corrective actions, including field safety corrective actions;btrends in incidents, including those on which the manufacturer must report under regulation 44ZN (trend reporting);coptions to improve the usability, performance and safety of the device;dany impact on the post-market surveillance of other devices.4The manufacturer must ensure that data gathered through the PMS system is used to update the following—afor devices placed on the market or put into service in accordance with Part 2 or 3—ithe instructions for use and labelling of the device;iidesign and manufacturing information;iiithe required risk analysis;ivthe evaluation of clinical data referred to in regulations 9(2) and 23(2) for the purposes of confirming conformity with the relevant essential requirements;vany other technical documentation required by the conformity assessment procedure carried out in respect of the device in accordance with Part 2 or 3.bfor devices placed on the market or put into service in accordance with Part 4—ithe instructions for use and labelling of the device;iidesign and manufacturing information;iiithe required risk analysis;ivany evaluation of performance evaluation data confirming conformity with the relevant essential requirements;vany other technical documentation required by the conformity assessment procedure carried out in respect of the device in accordance with Part 4.5Paragraph (4) does not apply in respect of a device placed on the market in accordance with regulation 19B, 19C, 30A, 44ZA or 44ZB.
Post-market surveillance plan
Regulation 44ZF
44ZF1The manufacturer must base the post-market surveillance system on a post-market surveillance plan (“PMS plan”) that complies with this regulation.2A PMS plan must be—aclear, organised and searchable, andbmaintained for the PMS period of the device model.3A PMS plan must specify the lifetime of the device and must include—aprocesses for the collection and assessment of the following information in relation to the device—iinformation about serious incidents, other incidents and side-effects;iiinformation about field safety corrective actions;iiiinformation for the purposes of identifying trends in incidents and if applicable, reporting those trends under regulation 44ZN (trend reporting);ivfeedback and complaints provided by users and suppliers of the device;vinformation about user experience in relation to safety and performance, including through patient and public engagement, where appropriate;viother information relevant to the post-market surveillance of the device, including information relating to similar devices available on the market and available outside Great Britain.bsuitable indicators and threshold values to be used in the reassessment of the required risk analysis;ceffective and appropriate processes to investigate complaints and analyse feedback and information about user experience;dprocesses to manage incidents and trends (whether or not they must be reported under regulation 44ZN (trend reporting)), including—ithe statistical methodology to be used to determine a significant increase in the frequency or severity of incidents, andiiin relation to a device placed on the market or put into service in accordance with Part 4, the statistical methodology to be used to determine a significant increase in expected erroneous results;ea process for communicating effectively with the Secretary of State, the approved body for the device (if there is one), the UK responsible person (if there is one), users and suppliers of the device;fprocesses that provide for how the manufacturer will comply with their obligations under this Part;ga plan for any post-market clinical follow-up required under Part 2 or 3;hthe post-market surveillance report required by regulation 44ZL (post-market surveillance report) or the periodic safety update report required by regulation 44ZM (periodic safety update report) and any reports issued by an approved body under paragraph (9) of regulation 44ZM.4The information collected under paragraph (3)(a) must enable—aan accurate characterisation of the performance of the device, andba comparison between the device and similar devices available on the market.5The manufacturer and the UK responsible person (if there is one) must provide the PMS plan, including any post-market surveillance reports or periodic safety update reports and any reports issued by an approved body, to the Secretary of State upon request and within 3 working days of the date of any such request.
Preventive and corrective actions
Regulation 44ZG
44ZG1If the manufacturer of a device—aidentifies a risk that following evaluation is deemed to compromise the performance or safety of the device, orbotherwise has reason to believe that the device is not in conformity with the relevant essential requirements,they must take the necessary preventive or corrective action as soon as possible to reduce that risk and bring the device into conformity.2The manufacturer must notify the action to—athe UK responsible person (if there is one);bthe approved body for the device (if there is one);cif the action is a field safety corrective action, the Secretary of State in accordance with regulation 44ZJ (field safety corrective action).3The approved body must review the notification to determine whether there is any impact on the certification it has issued for the device.4The manufacturer must monitor the action to identify if any further action is required to reduce the risk posed and bring the device into conformity.
Initial reporting of serious incidents
Regulation 44ZH
44ZH1The manufacturer must report to the Secretary of State any serious incident involving the manufacturer’s device.2The report must include—athe manufacturer’s name and contact details;bthe UK responsible person’s name and contact details (if there is one);cdetails of the initial reporter of the serious incident;da description of the device, including its current location and any unique device identifiers;ea description of the serious incident;fthe manufacturer’s preliminary conclusions in relation to the cause of the serious incident;gconsideration of whether any field safety corrective action is required to prevent or reduce the risk of a further serious incident;hdetails of any preventive or corrective action taken by the manufacturer.3The manufacturer must submit the report—aimmediately after the manufacturer has established the causal (or reasonably possible causal) relationship between the device and the serious incident, andbunless paragraph (4) or (5) applies, no later than 15 days after the manufacturer becomes aware of the serious incident.4If the serious incident being reported involves a serious public health threat, the report must be submitted no later than 2 days after the manufacturer becomes aware of the threat.5If there is a death or an unanticipated serious deterioration in a person’s state of health, the report must be submitted no later than 10 days after the manufacturer becomes aware of the incident.6If the same device model or a variant of that model is involved in similar serious incidents and the manufacturer has either—aidentified the cause, orbimplemented a field safety corrective action,the manufacturer and the Secretary of State may agree that the manufacturer can submit periodic summary reports instead of individual serious incident reports.
Investigation and final reporting of serious incidents
Regulation 44ZI
44ZI1After submitting a serious incident report under regulation 44ZH (initial reporting of serious incidents), the manufacturer must as soon as possible—ainvestigate the serious incident and the device or devices concerned,breview the required risk analysis for the device or devices concerned taking into account the serious incident and any proposed preventive and corrective actions, andcsubmit a final report to the Secretary of State setting out—ithe methods and conclusions of the investigation;iiconsideration of whether any field safety corrective action is required to prevent or reduce the risk of a further serious incident;iiidetails of any field safety corrective action the manufacturer has taken or intends to take;ivdetails of similar serious incidents involving the same device model or a variant of that model.2The Secretary of State may—agive advice to a manufacturer regarding the serious incident investigation;binitiate a separate investigation;crequire the approved body (if there is one) to provide information and assessments relevant to the serious incident and field safety corrective action.3A manufacturer must—acooperate with the Secretary of State in relation to the investigations referred to in paragraphs (1)(a) and (2)(b);bupon request, provide the Secretary of State with updates and documents relevant to an investigation referred to in paragraphs (1)(a) and (2)(b) and do so within 3 working days of the date of any such request;cnot perform any investigation which involves altering the device or a sample of the batch concerned in a way which may affect any subsequent evaluation of the causes of the serious incident, before informing the Secretary of State of such action.
Field safety corrective actions and field safety notices
Regulation 44ZJ
44ZJ1Unless paragraph (4) applies, before taking any field safety corrective action (“FSCA”) in relation to a device, a manufacturer must—aproduce a risk assessment of the proposed FSCA, andbsubmit to the Secretary of State—ian initial report on the proposed action, andiithe proposed field safety notice setting out the details in paragraph (6).2The initial report must include—athe manufacturer’s name and contact details;bthe UK responsible person’s name and contact details (if there is one);ca description of the devices, including any unique device identifiers;da description of the FSCA and its proposed implementation;ethe reason why the FSCA is required and the justification for the manufacturer’s chosen FSCA, based on the conclusions of the risk assessment produced under paragraph (1)(a);fthe number of devices placed on the market or put into service in Great Britain and the estimated number of users affected.3After submitting the initial report and proposed notice under paragraph (1), the manufacturer must implement the FSCA as soon as possible and monitor its progress.4A manufacturer may submit an initial report and a copy of the field safety notice after taking the FSCA if the manufacturer believes the FSCA needs to be taken urgently.5When taking an FSCA, the manufacturer must take all reasonable steps to ensure the field safety notice is sent to users of the device.6The field safety notice must—aidentify the devices involved and include any unique device identifiers in a searchable format within the notice;bexplain the reasons for the FSCA with reference to the risks to any person;cdescribe all actions to be taken by users in response.7After completing the FSCA, the manufacturer must submit a final report to the Secretary of State setting out the outcome of the action and including evidence to demonstrate its effectiveness.8The manufacturer must provide the Secretary of State with—athe risk assessment produced under paragraph (1)(a), andbupdates and evidence of the progress of the FSCA;upon request and within 3 working days of any such request.
Field safety corrective actions outside Great Britain
Regulation 44ZK
44ZK1A manufacturer of a device placed on the market or put into service in Great Britain must report to the Secretary of State when taking any field safety corrective action (“FSCA”) outside Great Britain, if—athe FSCA relates to a device which is of the same model as the device that has been placed on the market or put into service in Great Britain, andbthe manufacturer is not taking the same FSCA in Great Britain.2The report must include—athe manufacturer’s name and contact details;bthe UK responsible person’s name and contact details (if there is one);cdescriptions of the devices, including any unique device identifiers;dthe number of devices placed on the market or put into service in Great Britain and the estimated number of users;ea description of the FSCA and the reason why the FSCA is required outside Great Britain;fthe reason the same FSCA is not required in Great Britain.
Post-market surveillance report
Regulation 44ZL
44ZL1Subject to paragraph (4), the manufacturer must produce a post-market surveillance report (“PMSR”) for the following—aa device placed on the market in accordance with regulation 19B and classified as belonging to class I under Directive 93/42;ba device placed on the market in accordance with regulation 19C and classified as belonging to class I under Regulation (EU) 2017/745;ca device otherwise placed on the market or put into service in accordance with Part 2 and classified as belonging to class I under regulation 7 (classification of general medical devices);da device placed on the market in accordance with regulation 44ZB and classified as belonging to class A or B under Regulation (EU) 2017/746;ea device otherwise placed on the market or put into service in accordance with Part 4 that is not a device referred to in the lists in Annex II of Directive 98/79.2The PMSR must include—aa summary of the results and conclusions of the analyses of the information collected as a result of the post-market surveillance plan, andba description of any preventive or corrective action that has been taken by the manufacturer in relation to the device and the reason for doing so.3A PMSR must be—aproduced within 3 years of the device being placed on the market or put into service, whichever is sooner, andbupdated by the manufacturer at least every 3 years until the end of the PMS period for the device model.4This regulation shall not apply to a relevant device which is a system or procedure pack, unless–athe system or procedure pack incorporates a medical device which does not bear a UKCA marking or a CE marking; orbthe chosen combination of medical devices is not compatible in view of their original intended use.5In paragraph (2)(b) the reference to “any preventive or corrective action” includes any action taken before the device was placed on the market or put into service if—afor devices with a certificate that was issued by an approved body or notified body before the declaration of conformity was drawn up, the action was taken after that certificate was issued;bfor any other devices, the action was taken after the declaration of conformity was drawn up.
Periodic safety update report
Regulation 44ZM
44ZM1Subject to paragraph (4), unless regulation 44ZL (post-market surveillance report) applies to the device, the manufacturer must produce a periodic safety update report (“PSUR”) for each device placed on the market or put into service.2The manufacturer may prepare a single PSUR for a category or group of devices if—athe devices are covered by the same clinical evaluation report under Regulation (EU) 2017/745 or performance evaluation report under Regulation (EU) 2017/746, orbthe devices are similar devices and the manufacturer considers that the similarity between the devices justifies preparing a single PSUR for those devices.3The PSUR must include—aa summary of the results and conclusions of the analyses of the information collected as a result of the post-market surveillance plan;ba description of any preventive or corrective action that has been taken by the manufacturer in relation to the device and the reason for doing so;cthe required risk analysis;dthe conclusions of any post-market clinical follow-up required under Part 2 or 3;ethe number of—idevices placed on the market in the UK; andiidevices put into service in the UK without being placed on the market;fa description of the characteristics of the population using the device;gan estimate of—ithe size of the population using the device in the UK;iithe size of the population using the device outside the UK;iiithe usage frequency of the device, where it is practicable to make such an estimate.4This regulation shall not apply to a relevant device which is a system or procedure pack, unless—athe system or procedure pack incorporates a medical device which does not bear a UKCA marking or a CE marking; orbthe chosen combination of medical devices is not compatible in view of their original intended use.5In paragraph (3)(b), “any preventive or corrective action” includes any action taken before the device was placed on the market or put into service, if that action was taken after an approved body or notified body issued a certificate in respect of the device.6Unless paragraph (7) applies, the manufacturer must—aproduce the first PSUR within 1 year of the device being placed on the market or put into service, whichever is sooner, andbupdate the PSUR at least every year until the end of the PMS period for the device model.7This paragraph applies to—aa device placed on the market in accordance with regulation 19B and classified as belonging to class IIa under Directive 93/42;ba device placed on the market in accordance with regulation 19C and classified as belonging to class IIa under Regulation (EU) 2017/745;ca device otherwise placed on the market or put into service in accordance with Part 2 and classified as belonging to class IIa under regulation 7 (classification of general medical devices).8Where paragraph (7) applies, the manufacturer must—aproduce the first PSUR within 2 years of the device being placed on the market or put into service, whichever is sooner, andbupdate the PSUR at least every 2 years until the end of the PMS period for the device model.9The manufacturer must submit the PSUR and each updated PSUR to the approved body for the device (if there is one).10The approved body must take into account the PSUR and updated PSURs when carrying out its surveillance activities as part of a conformity assessment procedure set out in these Regulations.11In respect of a device listed in paragraph (12), the approved body must, as soon as reasonably practicable following receipt—areview the PSUR and each updated PSUR to determine whether there is any impact on the certification issued for the device, andbissue a report to the manufacturer and the UK responsible person (if there is one), setting out the conclusions of that review.12The devices referred to in paragraph (11) are—aa device placed on the market or put into service in accordance with Part 2 and classified as belonging to class III under regulation 7 (classification of general medical devices);ba device placed on the market or put into service in accordance with Part 2 and considered to be an implantable device under Directive 93/42;ca device placed on the market or put into service in accordance with Part 3;da device placed on the market or put into service in accordance with Part 4 that is referred to in the lists in Annex II of Directive 98/79.13The approved body must provide a copy of its completed reports under paragraph (11) to the Secretary of State upon request and within 3 working days of the date of any such request.
Trend reporting
Regulation 44ZN
44ZN1The manufacturer must report to the Secretary of State any significant increases in the frequency or severity of incidents involving a device if the manufacturer considers that increase could have a significant adverse impact on the required risk analysis.2A “significant increase” under paragraph (1) is to be determined in comparison to the foreseeable frequency or severity of the incidents and in accordance with the statistical methodology set out in the post-market surveillance plan.3In relation to a device placed on the market or put into service in accordance with Part 4, the manufacturer must also report to the Secretary of State any significant increase in expected erroneous results in comparison to the stated performance of the device in the instructions for use.4The reporting duties in paragraphs (1) and (3) apply throughout the PMS period for the device model.5An initial report under this regulation must include—athe manufacturer’s name and contact details;bthe UK responsible person’s name and contact details (if there is one);ca description of the device, including any unique device identifiers;dthe number of devices placed on the market or put into service in Great Britain and the estimated number of users affected;einformation in relation to the identified trend.6As soon as possible after submitting an initial report, the manufacturer must—ainvestigate the identified trend and the device or devices concerned, andbsubmit a final report to the Secretary of State setting out—ithe manufacturer’s conclusions into causes of the identified trend;iia description of any preventive and corrective actions taken or to be taken by the manufacturer in response to the identified trend.7The manufacturer must provide the Secretary of State with updates and documents relevant to the investigation under paragraph (6)(a) upon request and within 3 working days of the date of any such request.
Reports received by the Secretary of State
Regulation 44ZO
44ZO1The Secretary of State must record reports of incidents involving devices.2If the Secretary of State notifies a manufacturer about a reported incident, the manufacturer must consider whether the incident is a serious incident and take action in accordance with this Part.3If the manufacturer of the device considers that the incident is not a serious incident, the manufacturer must provide an explanatory statement to the Secretary of State as soon as possible.4If the Secretary of State notifies the manufacturer that the Secretary of State does not agree with an explanatory statement provided under paragraph (3), the manufacturer must take action in accordance with this Part as if the manufacturer considered the incident to be a serious incident.
Analysis of information received under Part 4A
Regulation 44ZP
44ZP1The Secretary of State must have processes for monitoring the information received under this Part, in order to identify trends, patterns or signals that may reveal new risks or safety concerns.2If the Secretary of State notifies a manufacturer of an identified risk or safety concern, the manufacturer must investigate the risk or safety concern and submit a report to the Secretary of State as soon as possible setting out—athe methods and conclusions of the manufacturer’s investigation, andbany preventive action or corrective action the manufacturer has taken or intends to take.3Paragraph (2) is without prejudice to any other investigation and reporting requirements in this Part.
Retention of post-market surveillance documentation
Regulation 44ZQ
44ZQ1The manufacturer and the UK responsible person (if there is one) must retain the documentation drawn up for the purposes of this Part for the period set out in paragraph (2).2The period is the longer of—athe PMS period for the device model, andb15 years in the case of an implantable device, or 10 years in the case of any other device.
Requests for post-market surveillance documentation
Regulation 44ZR
44ZRWhere any provision of this Part requires information or documentation to be provided to the Secretary of State within 3 working days of a request, the Secretary of State may extend the time within which the information or documentation is to be provided if the Secretary of State considers it reasonable to do so.
PART V — Notified Bodies Approved Bodies, Conformity Assessment Bodies and Marking of Products
Interpretation of Part V
Regulation 44A
44AIn this Part, “medical device” means a device that is a “relevant device” for the purposes of Part II, III or IV.
Meaning of approved body and UK notified body
Regulation A45
A451An approved body is a conformity assessment body which—ahas been designated by the Secretary of State pursuant to the procedure set out in regulation 45 (designation etc. of approved bodies); orbimmediately before IP completion day was a UK notified body in respect of which the Secretary of State has taken no action under regulation 45(5) to withdraw a designation.2In this regulation—“UK notified body” means a body which the Secretary of State had before IP completion day notified to the European Commission in accordance with Article 3(7) of Commission Implementing Regulation (EU) 920/2013 or under Article 15 of Directive 98/79.”.
Designation etc. of approved bodies
Regulation 45
451The Secretary of State may designate for the purposes of these Regulations any corporate or other body as a body which is to carry out any of the tasks of an approved body, and, if he so designates a body (referred to in these Regulations as an “approved body”), he shall designate the tasks which it is to carry out.2A body may be designated under paragraph (1) as a body which is to carry out tasks of an approved body only if—ain so far as it is to be designated as a body which is to carry out tasks included in Part III, it is a body in respect of which the criteria for the designation of approved bodies set out in Annex 8 of Directive 90/385 , read with Regulation (EU) No 722/2012, are met;bin so far as it is to be designated as a body which is to carry out tasks included in Part II, it is a body in respect of which the criteria for the designation of approved bodies set out in Annex XI of Directive 93/42 , read with Regulation (EU) No 722/2012, are met;cin so far as it is to be designated as a body which is to carry out tasks included in Part IV, it is a body in respect of which the criteria for the designation of approved bodies set out in Annex IX of Directive 98/79 are met; anddin so far as it needs to be able to fulfil the functions of an importing Party arising out of a mutual recognition agreement, it is able to do so.3The Secretary of State may refuse to designate a body under paragraph (1) if it fails to pay any fee payable under Part VI in connection with an application for designation.4The Secretary of State may vary the tasks that an approved body may carry out, and if he does, those varied tasks will be the tasks which it is designated to carry out.5The Secretary of State may place a restriction in relation to, or withdraw, any designation of a body under paragraph (1) if—athe body so requests;bhe considers that it is no longer a body in respect of which the applicable criteria for designation set out in Annex 8 of Directive 90/385, Annex XI of Directive 93/42, both read with Regulation (EU) No 722/2012 or Annex IX of Directive 98/79 are met; orche considers that the body is not capable of fulfilling the functions of an importing Party arising out of a mutual recognition agreement which it needs to be able to fulfil,and the Secretary of State may also withdraw any designation of a body under paragraph (1) if it fails to pay any fee payable under Part VI.6Before—aeffecting a variation under paragraph (4); orbrestricting or withdrawing a designation under paragraph (5),otherwise than at the approved body’s request, the Secretary of State shall give to the approved body an opportunity to make representations to him in writing and shall take into account any such representations as are made.7For the purpose of deciding whether or not a body is one in respect of which the criteria set out in Annex 8 of Directive 90/385, Annex XI of Directive 93/42, both read with Regulation (EU) No 722/2012 or Annex IX of Directive 98/79 are met as respects the tasks which the body wants to carry out, or carries out, or for the purposes of deciding whether or not a body is capable of fulfilling the functions of an importing Party arising out of a mutual recognition agreement which it needs to be able to fulfil, the Secretary of State may arrange for the inspection of—aany premises occupied, or plant or equipment used, in connection with the carrying out of any such task; orbany premises occupied, or plant or equipment used, by a manufacturer where the body is undertaking any task in relation to that manufacturer,and may take into account for the purposes of his decision the results of any such inspection and any refusal to afford him such facilities or assistance as he may reasonably require in order to carry out any such inspection.8The Secretary of State may request that an approved body supply to him any or all relevant information and documents, including budgetary documents, necessary—ato enable him to verify that the body meets the criteria set out in Annex 8 of Directive 90/385, Annex XI of Directive 93/42, both read with Regulation (EU) No 722/2012, or Annex IX of Directive 98/79; orbfor the purposes of deciding whether or not the body is capable of fulfilling the functions of an importing Party arising out of a mutual recognition agreement which it needs to be able to fulfil,and the body shall supply to him any and all relevant information or documents so requested.
Choice of approved bodies and conformity assessment bodies
Regulation 46
46Where a conformity assessment procedure involves the intervention of an approved body, including work which may be carried out by a third country conformity assessment body, the manufacturer of a device or the manufacturer’s UK responsible person may apply to any approved body or third country conformity assessment body to carry out tasks under that procedure which are within the framework of tasks which the body is designated to carry out.
General matters relating to approved bodies
Regulation 47
471An approved body to which an application has been made by a manufacturer or the manufacturer’s UK responsible person to perform the functions of an approved body under a conformity assessment procedure set out in these Regulations shall perform those functions, in accordance with the requirements of the procedure, if those functions are within the framework of tasks which the body is designated to carry out.2Where a manufacturer or the manufacturer’s UK responsible person has supplied information or data to an approved body in the course of a conformity assessment procedure, that body may, where duly justified, require the manufacturer to provide any additional information or data which it considers necessary for the purposes of that procedure.3The information, data and correspondence that a manufacturer or the manufacturer’s UK responsible person supplies to an approved body in the course of a conformity assessment procedure set out in these Regulations shall, ..., be in English ....4 An approved body shall, as respects a medical device which it has assessed ..., inform all other approved bodies and the Secretary of State of—aall certificates suspended or withdrawn; andbon request, all certificates issued or refused,and shall also make available to them, on request, any or all additional relevant information.5Where an approved body finds, as respects a medical device which it has assessed ..., that—athe applicable requirements of these Regulations have not been met or are no longer met; orba certificate issued by it should not have been issued,it may (having regard in particular to the principle of proportionality and the ability of the manufacturer to take appropriate corrective measures) suspend or withdraw the certificate issued in respect of that device or place restrictions on it, and in such cases, or in cases where the approved body is aware of circumstances in which the Secretary of State may need to take action pursuant to regulation 61, the approved body shall inform the Secretary of State thereof.6The Secretary of State may request that an approved body supply to him any information and documents that the Secretary of State may, having regard to the terms of a mutual recognition agreement, need to supply to a Party to a mutual recognition agreement, and the body shall supply to him any and all information or documents so requested.8An approved body shall provide conformity assessment bodies with all the information it is required to provide to those bodies under a mutual recognition agreement.9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Register of approved bodies
Regulation 47A
47A1The Secretary of State must ensure that—aeach approved body is assigned an identification number; andbthere is a register of—iapproved bodies;iitheir approved body identification number;iiithe tasks for which they have been designated; andivany restrictions on those tasks.2The Secretary of State must ensure that the register referred to in paragraph (1) is maintained and made publicly available.3The Secretary of State may authorise the United Kingdom Accreditation Service to compile and maintain the register in accordance with paragraph (1)(b).
Designation etc. of ... conformity assessment bodies
Regulation 48
481The Secretary of State may designate for the purposes of a mutual recognition agreement any corporate or other body as a body which is to carry out any of the tasks of a ... conformity assessment body, and, if he so designates a body (referred to in these Regulations as a “CAB”), he shall designate the tasks which it is to carry out.2A body may be designated under paragraph (1) as a body which is to carry out tasks of a CAB only if the Secretary of State considers that the body is capable of fulfilling the functions of a CAB arising out of a mutual recognition agreement which it needs to be able to fulfil.3The Secretary of State may refuse to designate a body under paragraph (1) if it fails to pay any fee payable under Part VI in connection with an application for designation.4The Secretary of State may vary the tasks that a CAB may carry out, and if he does, those varied tasks will be the tasks which it is designated to carry out.5The Secretary of State may place a restriction in relation to, or withdraw, any designation of a body under paragraph (1) if—athe body so requests; orbhe considers that the body is not capable of fulfilling the functions of a CAB arising out of a mutual recognition agreement which it needs to be able to fulfil,and the Secretary of State may also withdraw any designation of a body under paragraph (1) if it fails to pay any fee payable under Part VI.6Before—aeffecting a variation under paragraph (4); orbrestricting or withdrawing a designation under paragraph (5),otherwise than at the ... CAB’s request, the Secretary of State shall give to the ... CAB an opportunity to make representations to him in writing and shall take into account any such representations as are made.7For the purpose of deciding whether or not a body is capable of fulfilling the functions of a CAB arising out of a mutual recognition agreement which it needs to be able to fulfil, the Secretary of State may arrange for the inspection of—aany premises occupied, or plant or equipment used, in connection with the carrying out of any such task; orbany premises occupied, or plant or equipment used, by a manufacturer where the body is undertaking any task in relation to that manufacturer,and may take into account for the purposes of his decision the results of any such inspection and any refusal to afford him such facilities or assistance as he may reasonably require in order to carry out any such inspection.8The Secretary of State may request that a CAB supply to him any or all relevant information and documents, including budgetary documents, necessary for the purposes of deciding whether or not the body is capable of fulfilling the functions of a CAB arising out of a mutual recognition agreement which it needs to be able to fulfil, and the body shall supply to him any and all relevant information or documents so requested.
Fees charged by approved bodies and conformity assessment bodies
Regulation 49
491 An approved body or CAB may charge a fee in accordance with paragraphs (2), (3) and (4) for anything done in, or in connection with—ain the case of an approved body, performing the functions of an approved body or an importing Party under these Regulations or a mutual recognition agreement; andbin the case of a CAB, performing the functions of a CAB arising out of a mutual recognition agreement in respect of a conformity assessment procedure for a medical device.2Except as provided for by paragraph (3), the fee charged in respect of anything done shall not exceed an amount which reasonably represents the cost incurred, or to be incurred, in doing it.3Where the approved body or CAB charging the fee is a body the activities of which are carried on for profit, the fee may include an amount representing a profit which is reasonable in the circumstances, having regard to—athe character and extent of the work done or to be done by the approved body; andbthe commercial rate normally charged in respect of profit for that work or similar work.4The approved body or CAB may require payment of the fee, or a reasonable estimate of the fee, in advance of carrying out the work in respect of which the fee is payable and as a condition of doing that work.
Products incorrectly marked with an approved body or conformity assessment body number
Regulation 50
501No person shall—aaffix an approved body or conformity assessment body number to a medical device if that body has not carried out an assessment in respect of that device for that person;bsupply a medical device (if that supply is also a placing on the market, or if that supply is of a device which has been placed on the market) which has affixed to it an approved body or conformity assessment body number if that body—ihas not carried out an assessment in respect of that device, or has not carried out that assessment for the person responsible for placing the device on the market, oriihas had its designation as an approved body or conformity assessment body withdrawn.2No person shall provide information comprising an approved body or conformity assessment body number on a medical device, the instructions for use for a medical device, or the sales packaging for a medical device if that device—ais being or has been placed on the market; andb the approved body or conformity assessment body—ihas not carried out an assessment in respect of that device, or has not carried out that assessment for the person responsible for placing the device on the market, oriihas had its designation as an approved body or conformity assessment body withdrawn.3Where the sectoral annex on medical devices in a Mutual Recognition Agreement under which a conformity assessment body was designated states that the annex does not apply to devices of a particular class or description, no person may supply a medical device of that class or description bearing the number of that conformity assessment body (if that supply is also a placing on the market or putting into service or is of a device that has been placed on the market or put into service) unless—aan assessment has been carried out on that device for the person responsible for placing it on the market or putting it into service by an approved body; andbthe device bears the approved body number of that approved body.4For the purposes of this regulation, an approved body shall be taken to have carried out an assessment in respect of a device if it has endorsed a report prepared by a third country conformity assessment body in respect of that device.
Products incorrectly marked with a UK marking
Regulation 51
511No person shall—aaffix the UK marking for a medical device to a product which is not a medical device; orbsupply a product (if that supply is also a placing on the market, or if that supply is of a product which has been placed on the market) which has affixed to it the UK marking for a medical device if that product is not a medical device.2No person shall provide information comprising a UK marking for a medical device on a product, the instructions for use for a product, or the sales packaging for a product if the product is not a medical device.
PART VI — Fees charged by the Secretary of State
Interpretation of Part VI
Regulation 52
521In this Part...— “approved manufacturer” in relation to a medicinal substance means a manufacturer who—holds a manufacturing authorisation which permits the manufacturer to manufacture that substance for inclusion in an authorised medicinal product; orholds an examination certificate for a device incorporating that medicinal substance and that certificate was issued by an approved body or notified body after consultation with the Secretary of State in respect of that substance; “authorised medicinal product” means a medicinal product in respect of which a marketing authorisation has been granted; “clinical development” means the conduct of studies of a medicinal substance in human subjects in order to—discover or verify the effects of such a substance,identify any adverse reaction to such a substance, orstudy absorption, distribution, metabolism and excretion of such a substance,with the object of ascertaining the safety or efficacy of that substance, as required to verify the safety and usefulness of the substance in accordance with section 7.4 of Annex I of Directive 93/42 and section 10 of Annex I of Directive 90/385; “consultation” means a consultation required by—section 4.3 of Annex II of Directive 93/42 or Directive 90/385; orsection 5 of Annex III of Directive 93/42 or Directive 90/385; “examination certificate” means—a design-examination certificate within the meaning of sections 4.3 and 4.4 of Annex II of Directive 93/42 or Directive 90/385, issued by an approved body;a type-examination certificate within the meaning of sections 5 and 6 of Annex III of Directive 93/42 or Directive 90/385, issued by an approved body;an EC design-examination certificate within the meaning of sections 4.3 and 4.4 of the version of Annex II of Directive 93/42 or Directive 90/385 that existed immediately before IP completion day, issued by a notified body; oran EC type-examination certificate within the meaning of sections 5 and 6 of the version of Annex III of Directive 93/42 or Directive 90/385 that existed immediately before IP completion day), issued by a notified body; “further consultation” means a consultation by an approved body in relation to any device which—may be placed on the market or put into service in accordance with Part 2 or 3 and which is the subject of an examination certificate issued by that approved body after consultation with the Secretary of State;is the subject of proposed changes within section 4.4 of Annex II of Directive 93/42 or Directive 90/385 or section 6 of Annex III of Directive 93/42 or Directive 90/385 and if that device is to be placed on the market or put into service, those changes may require a supplement to the examination certificate previously issued by that approved body after consultation with the Secretary of State; oris of a similar design or type to a device which has been the subject of an unsuccessful application for an examination certificate where—the person who made that unsuccessful application makes a further application for an examination certificate to the approved body which determined that unsuccessful application; andwithin the relevant period that further application becomes the subject of consultation between that approved body and the Secretary of State; “Group A device” means a Class I medical device, a Class IIa medical device, or a Class IIb medical device which is neither an implantable device nor a long term invasive medical device;“Group B device” means a Class IIb medical device which is either an implantable medical device or a long term invasive medical device, or a Class III medical device, or an active implantable medical device; and “half day” means a period of three and a half hours. “incorporates” means incorporates as an integral part; “marketing authorisation” has the meaning given by regulation 8 of the Human Medicines Regulations 2012; “medicinal substance” means a substance which, if used separately from a device, may be considered to be a medicinal product, as defined in Schedule 1 to the Medicines (Products for Human Use) Fees Regulations 2016; “new medicinal substance” means a medicinal substance which is not—an authorised medicinal product;an ingredient or, as the case may be, the sole active ingredient of such a product; ora substance which has been incorporated in a device in respect of which an examination certificate has been issued by an approved body which has consulted the Secretary of State; “quality development” means the chemical, pharmaceutical and biological testing required in order to verify the quality of a medicinal substance in accordance with paragraph 7.4 of Annex I of Directive 93/42 and section 10 of Annex I of Directive 90/385; “relevant period” means the period of 5 years which starts on the first day on which the Secretary of State was consulted in respect of the unsuccessful application or, if there has been more than one such application in any particular case, in respect of the first of them; “safety development” means the toxicological and pharmacological testing required in order to verify the safety of a medicinal substance in accordance with paragraph 7.4 of Annex I of Directive 93/42 and section 10 of Annex I of Directive 90/385; and “scientific advice” means advice in connection with the quality, safety or clinical development for a medicinal substance incorporated, or to be incorporated, in a device. 2For the purposes of this Part, medical devices are classified as being implantable or long term invasive medical devices in accordance with the definitions set out in Section 1 of Annex IX of Directive 93/42, and in the event of a dispute over the classification of a device, the Secretary of State shall determine the classification of the device in accordance with the definitions set out in Section 1 of Annex IX of Directive 93/42.
Fees in connection with the registration of devices and changes to registration details
Regulation 53
531Any person required to supply the Secretary of State with any information under regulation 7A, 19, 21A, 33A or 44 shall, in respect of the processing of that information with regard to the possible registration of that person by the Secretary of State or possible changes to his registration details, pay to the Secretary of State a fee of £300, and that fee—ashall be payable when the information is supplied by that person to the Secretary of State; andbshall accompany that information when it is supplied.2Any person who has a registration in accordance with regulation 7A, 19, 21A, 33A or 44 shall, in respect of the maintenance of that registration by the Secretary of State, pay to the Secretary of State an annual fee of £300 for each device registered and that fee—ashall be payable for each fee period during which the registration is maintained, starting with the fee period immediately following that in which the person paid the fee for the device registration in accordance with paragraph (1); andbshall be due on the first day of each fee period in relation to which a fee is payable.3Where a person is liable to pay a fee under this regulation in respect of a device, no fee is payable under this regulation for an additional device which has the same registration category (whether registered simultaneously or subsequently, and whether the additional device also has other registration categories or not).4Where a person supplies information referred to in paragraph (1) after the first day of a fee period, then the amount of the fee due in accordance with paragraph (1) shall be adjusted, pro rata, starting with the day on which the information is supplied, in accordance with the remaining number of days in the fee period.5A person may not place a device on the market unless they have paid all fees for which they are liable under this regulation, whether or not those fees relate to that device.6Where a person has registered a device under this regulation prior to 1st April 2026, the first fee period for which a fee is payable under paragraph (2) begins on 1st April 2026 and ends on 31st March 2027.7In this regulation—“fee period” means the period beginning with 1st April in any year and ending with 31st March in the following year;“Global Medical Device Nomenclature” means the standard for the naming and categorisation of medical devices as maintained by the GMDN Agency, a company with registered company number 05392271, or any successor to that company;“maintenance”, in relation to a registration, includes—holding information supplied in relation to a registration;regulatory oversight by the Secretary of State;monitoring, identification, and addressing of safety issues by the Secretary of State in relation to the device registered.“registration category” means, in accordance with the Global Medical Device Nomenclature as at the first day of the relevant fee period—a Level 2 Category; orwhere there is no applicable category under sub-paragraph (a), a Level 1 Category.
Fees payable in connection with the designation of approved bodies
Regulation 54
541A corporate or other body that applies to the Secretary of State for designation under regulation 45 as an approved body shall, in connection with that application for designation, pay to the Secretary of State—aif it is the second or subsequent such application and the application is being made only to address the grounds for rejection of a previous application, a fee of £10,335; orbin all other cases, a fee of £41,337.2A corporate or other body that applies to the Secretary of State for a variation under regulation 45(4) must, in connection with that application for a variation, pay to the Secretary of State—ain respect of an extension to the scope of the body’s designation to carry out tasks under Part 2, Part 3 or Part 4, which extends the body’s designation in relation to a Part under which they have already been designated, a fee of £14,568;bin respect of an extension to the scope of the body’s designation, which extends the body’s designation to carry out certain tasks that were not previously within the scope of the body’s designation and where the Secretary of State considers that an additional assessment of the body’s procedures is required, a fee of £21,105.3Where, pursuant to regulation 45(7) the Secretary of State inspects premises for the purposes of deciding whether or not a body is one in respect of which the criteria set out in Annex 8 of Directive 90/385, Annex XI of Directive 93/42, both read with Regulation (EU) No 722/2012 or Annex IX of Directive 98/79 are met, or for the purposes of deciding whether or not a body is capable of fulfilling the functions of an importing Party arising out of a mutual recognition agreement which it needs to be able to fulfil, the body shall pay to the Secretary of State—ain respect of an initial inspection pursuant to regulation 45(7)(a), a fee of £67,606 plus the amounts specified in paragraph (3A);bin respect of an inspection pursuant to regulation 45(7)(a), other than an initial inspection, a fee of £52,929, plus the amounts specified in paragraph (3A); andcin respect of an inspection pursuant to regulation 45(7)(b), a fee of £11,672 plus the amounts specified in paragraph (3A).3ASubject to paragraph (3B), the additional amounts payable in respect of an inspection referred to in paragraph (3) shall be—aan amount for time spent by a member of staff undertaking a site visit at a rate—ifor the time spent on site, of £732 per half day (periods of less than a half day counting as a half day) up to a maximum of two half days on any one date, andiifor the time spent travelling to and from the site, of £198 per hour;bthe actual costs of travel, accommodation and subsistence; andcout of pocket expenses.3BWhere the Secretary of State conducts an inspection referred to in paragraph (3)(a) on the same date and at the same premises as an inspection pursuant to regulation 48(7)(a)—athe amount referred to in paragraph (3A)(3) shall include an amount for any time spent on site by a member of staff which is attributable to the conduct of the inspection pursuant to regulation 48(7)(a), at the rate referred to paragraph (3A)(a)(i); andbthe costs and expenses referred to in paragraph (3A)(b) and (c) shall include any additional costs and expenses attributable to the conduct of the inspection pursuant to regulation 48(7)(a).3CAn approved body that applies to the Secretary of State for a renewal of its designation pursuant to article 4 of Regulation (EU) No 920/2013 shall pay to the Secretary of State—aa fee of £41,337 in respect of the application; andbwhere an audit is carried out in connection with the application, a fee of £67,606 in respect of the audit , plus the amounts specified in paragraph (3A). 3DWhere the Secretary of State conducts an assessment of an approved body pursuant to article 5 of Regulation (EU) No 920/2013, the approved body shall pay to the Secretary of State—aif the assessment relates to the UK notified body’s assessment of clinical data only, a fee of £21,535; orbin any other case, a fee of £26,408 , plus the amounts specified in paragraph (3A). 3E An approved body that submits a summary evaluation report to the Secretary of State pursuant to article 5(4) of Regulation (EU) No 722/2012 shall pay to the Secretary of State a fee of £1,503.3FWhere, pursuant to regulation 45(7)(a) or 45(7)(b), the Secretary of State conducts an on-site assessment of a subsidiary of the body, the body must pay to the Secretary of State a fee of £26,408, plus the costs and expenses referred to in paragraph (3A).4A fee under this regulation—ain connection with an application for designation under regulation 45(1), a variation under regulation 45(4) , a renewal under Regulation (EU) No 920/2013 (but not any associated audit) or a submission of a summary evaluation report under Regulation (EU) No 722/2012—ishall be payable when the application or submission to the Secretary of State is made, andiishall accompany the application or submission when it is made;bin connection with an inspection pursuant to regulation 45(7) or an audit or assessment pursuant to Regulation (EU) No 920/2013, shall be payable within one month of receipt by the body of a written notice from the Secretary of State requiring payment of the fee.5In this regulation—“Regulation (EU) No 920/2013” means Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices; and“subsidiary” is to be construed in accordance with section 1159 of the Companies Act 2006.
Fees payable in connection with the designation etc. of ... conformity assessment bodies
Regulation 55
551A corporate or other body that applies to the Secretary of State for designation under regulation 48 as a CAB shall, in connection with that application for designation, pay to the Secretary of State—aif it is the second or subsequent such application and the application is being made only to address the grounds for rejection of a previous application, a fee of £10,335; orbin all other cases, a fee of £41,337.2A corporate or other body that applies to the Secretary of State for a variation under regulation 48(4) must, in connection with that application for a variation, pay to the Secretary of State—ain respect of an extension to the scope of the body’s designation to carry out tasks arising out of a mutual recognition agreement that were not previously within the scope of the body’s designation, a fee of £14,568; orbin respect of an extension to the scope of the body’s designation, which extends the body’s designation to carry out certain tasks that were not previously within the scope of the body’s designation and which requires the Secretary of State to undertake an additional assessment of the body’s procedures, a fee of £21,105.3 Subject to paragraphs (3A) to (3C) where, pursuant to regulation 48(7) the Secretary of State inspects premises for the purposes of deciding whether or not a body is capable of fulfilling the functions of a CAB arising out of a mutual recognition agreement which it needs to be able to fulfil, the body shall pay to the Secretary of State—ain respect of an initial inspection pursuant to regulation 48(7)(a), other than an inspection referred to in sub-paragraph (c), fee of £67,606 plus the amounts specified in paragraph (3D);bin respect of any other inspection pursuant to regulation 48(7)(a), other than an inspection referred to in sub-paragraph (c), a fee of £11,672 plus the amounts specified in paragraph (3D);cin respect of an inspection pursuant to regulation 48(7)(a) conducted on the same date and at the same premises as an inspection pursuant to regulation 45(7), a fee of £1,880;din respect of an inspection pursuant to regulation 48(7)(b), a fee of £11,672 plus the amounts specified in paragraph (3D).3AWhere the Secretary of State conducts two or more inspections pursuant to regulation 48(7)(a) on the same date and at the same premises, other than inspections referred to in paragraph (3)(c), and one of the inspections is an initial inspection, the fee payable shall be £67,606 plus—a £1,880 for each additional inspection; andbthe amounts specified in paragraph (3D).3BWhere the Secretary of State conducts two or more inspections pursuant to regulation 48(7)(a) on the same date and at the same premises, other than inspections referred to in paragraph (3)(c), and none of the inspections is an initial inspection, the fee payable shall be £11,672 plus—a £1,880 for each additional inspection; andbthe amounts specified in paragraph (3D)3CWhere the Secretary of State conducts two or more inspections referred to in paragraph (3)(c) on the same date and at the same premises, the fee payable for the inspections pursuant to regulation 48(7)(a) shall be £1,880 for each inspection.3DThe additional amounts payable in respect of an inspection referred to in paragraphs (3) to (3B) shall be—aan amount for time spent by a member of staff undertaking a site visit at a rate—ifor the time spent on site, of £732 per half day (periods of less than a half day counting as a half day) up to a maximum of two half days on any one date, andiifor the time spent travelling to and from the site, of £198 per hour;bthe actual costs of travel, accommodation and subsistence, andcout of pocket expenses.4A fee under this regulation—ain connection with an application for designation under regulation 48(1) or a variation under regulation 48(4)—ishall be payable when the application to the Secretary of State is made, andiishall accompany the application when it is made;bin connection with an inspection pursuant to regulation 48(7), shall be payable within one month of receipt by the body of a written notice from the Secretary of State requiring payment of the fee.
Fees payable in relation to clinical investigation notices
Regulation 56
561Subject to paragraph (2), any person required to give the Secretary of State notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) shall, in respect of the consideration by the Secretary of State of the information that the person is required to submit, pay to the Secretary of State—aif, as regards that device, it is the second or subsequent occasion on which the person has given the Secretary of State notice of an intended clinical investigation, and the changes from the immediately preceding notice are limited to addressing the grounds on which the Secretary of State has refused or withdrawn permission to hold a clinical investigation—ia fee, if the device is a Group A device, of £11,701, oriia fee, if the device is a Group B device, of £22,678; orbin all other cases—ia fee, if the device is a Group A device, of £15,309, oriia fee, if the device is a Group B device, of £32,016.2Except where paragraph (3) or (3A) applies, no fee shall be payable in respect of a notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) where the manufacturer or their UK responsible person has previously given such notice in relation to that device.3A fee shall be payable where the investigational plan which forms part of the statement accompanying the notice differs from the plan submitted with the immediately preceding notice in that it includes—aa change to address the grounds on which the Secretary of State has refused or withdrawn permission to hold a clinical investigation;ba change to the number of patients or devices forming the basis of the proposed trial;ca change or extension in the indications for use of the device or to the purpose or objectives of the trial;da change in any of the materials used in the device that come into direct contact with the human body if the new materials are not known to be biocompatible; orea change in the design of the device involving a novel feature not previously tested, being a change that has a direct effect on a vital physiological function.3AAny person who submits an amendment to a notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) shall pay to the Secretary of State—aa fee, if the device is a Group A device, of £226; orba fee, if the device is a Group B device, of £361.3BA person who requests a meeting with the Secretary of State in respect of an intended clinical investigation under regulation 16(1A) or 29(1A) must pay the following fees in advance of the meeting—a£987 for a regulatory advice meeting under regulation 16(1A)(a) or 29(1A)(a); andb£852 for a statistical review meeting under regulation 16(1A)(b) or 29(1A)(b).4A fee under this regulation—ashall be payable when the notice to which it relates is given to the Secretary of State; andbshall accompany that notice when it is given.
Fees in connection with approval of coronavirus test devices
Regulation 56A
56A1A person who makes an application to the Secretary of State under regulation 38A(1) must pay to the Secretary of State a fee of—a£14,000; orbif the person is a small or medium-sized enterprise, £6,200.2Where the Secretary of State, in accordance with regulation 38A(4), treats an application made before the coming into force of regulation 38A as an application made under that regulation, a payment made in respect of that application before the coming into force of this regulation must be treated as—aa payment meeting the requirements of paragraph (1), if that payment would have met those requirements after their coming into force; orba payment contributing in part to the payment required by paragraph (1), if that payment would not have met those requirements after their coming into force.3In this regulation—aa person is a small or medium-sized enterprise if it and persons associated with it employ no more than 250 individuals in total; andb“persons associated with it” has the same meaning as in section 882 of the Corporation Tax Act 2010.
Circumstances in which a fee is payable in relation to a consultation on the safety, quality and usefulness of a medicinal substance incorporated in a device
Regulation 56B
56B1Subject to paragraph (2), the fee payable by an approved body in respect of a consultation or further consultation with the Secretary of State in relation to the safety, quality and usefulness of a medicinal substance incorporated in a device is the fee specified in regulation 56C.2No fee is payable if it is the first time the Secretary of State has been consulted by any approved body in relation to the safety, quality and usefulness of a medicinal substance incorporated in a device if the medicinal substance is an authorised medicinal product.
Fees payable in connection with a consultation or further consultation on the safety, quality and usefulness of a medicinal substance incorporated in a device
Regulation 56C
56C1Subject to regulation 56B(2) and paragraph (3), the fee in respect of a consultation in relation to a device which incorporates one or more medicinal substances is—a£4,953 if each medicinal substance is manufactured by an approved manufacturer of that substance;b£11,543 if any of the medicinal substances are not manufactured by an approved manufacturer of that substance.2Subject to paragraph (3), the fee in respect of a further consultation in relation to a device which incorporates one or more medicinal substances is—a£980 if each medicinal substance is manufactured by an approved manufacturer of that substance;b£2,668 if any of the medicinal substances are not manufactured by an approved manufacturer of that substance.3In relation to a device which incorporates a new medicinal substance, the fee is—a£50,644 for a consultation; andb£12,574 for a further consultation.4Where an approved body consults the Secretary of State in relation to more than one device at the same time and those devices—aare of similar construction and are designed to perform similar functions;bincorporate medicinal substances of the same specification which are manufactured by the same manufacturer or manufacturers; andcdo not incorporate any other medicinal substance;the fee payable for that consultation is the fee which would be payable under this regulation for a consultation in relation to one of those devices.5Any fee payable under this regulation must be paid to the Secretary of State not later than the day on which an approved body consults the Secretary of State.
Fees payable in connection with pre-consultation meetings
Regulation 56D
56D. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fees payable in connection with regulatory advice meetings
Regulation 56E
56E1Unless regulation 56(3B)(a) applies, or regulation 17A(2)(a) of the Medical Devices (Northern Ireland Protocol) Regulations 2021 applies, the fee payable by a person with whom the Secretary of State holds a meeting in order to provide regulatory advice relating to a medical device is £987 for each hour that meeting takes.2Any fee payable under this regulation must be paid within 14 days following written notice from the Secretary of State requiring payment of that fee.
Unpaid fees
Regulation 57
57All unpaid sums due by way of, or on account of, any fees payable under this Part are recoverable as debts due to the Crown.
Waivers, reductions and refunds
Regulation 58
581The Secretary of State may—awaive payment of any fee or reduce any fee or part of a fee otherwise payable under this Part;brefund the whole or part of any fee paid pursuant to this Part.2Without prejudice to the generality of paragraph (1), where—aa notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) is withdrawn within the period of 7 days beginning with the date of its receipt by the Secretary of State; orban application for designation as—ian approved body under regulation 45(1), orii a CAB under regulation 48(1),(other than one submitted only to address the grounds of rejection of a previous application) is withdrawn within the period of 21 days beginning with the date of its receipt by the Secretary of State,the fee payable shall be reduced to fifty per cent of the fee otherwise payable in respect of such notice or application, and any excess already paid shall be refunded.
Time for payment of fees - small companies
Regulation 58A
58A1Where a fee in regulation 56(1) is payable by a small company, if the small company so requests to the Secretary of State in writing, 50% of that fee shall be payable when the notice to which it relates is given to the Secretary of State and 50% of that fee shall be payable within six months of the date when the notice is given.2For the purpose of this regulation, a company is a small company if, for the financial year before that in which the notice is given, the total value of products it has sold or supplied for the financial year is not more than the amount specified in item 1 in section 382(3) (qualification of company as small) of the Companies Act 2006 and either—athe company’s balance sheet total as defined in section 382(5) of the Companies Act 2006 is not more than the amount specified in item 2 in section 382(3) of that Act; orbthe average number of persons employed by the company in the financial year before that in which the notice is given (determined on a weekly basis) does not exceed the number specified in item 3 in section 382(3) of that Act.3In this regulation, a reference to section 382 of the Companies Act 2006 is a reference to that section as amended by the Companies (Accounts and Reports) (Amendment and Transitional Provision) Regulations 2024.
PART VII — General, Enforcement and Miscellaneous
Interpretation of Part VII
Regulation 59
59In this Part ...—“registrable device” means a device in respect of which, in accordance with the Medical Devices Directives, registration is required with the competent authorities of a Member State or (where appropriate) a State which is a Party to an Association Agreement;“relevant device” means a device that is a “relevant device” for the purposes of Part II, III or IV ....
Status of UK responsible person
Regulation 60
601. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3A UK responsible person—amay be proceeded against as a person placing the device on the market for the purposes of these regulations;bin relation to the supply of the device to a person within the United Kingdom after it has been placed on the market, may be proceeded against as a person supplying the device after it has been placed on the market.4If a person claims or purports to act as a UK responsible person, the Secretary of State may, for the purposes of enabling the Secretary of State to exercise his functions under these Regulations, require that person to furnish the Secretary of State with sufficient evidence that he is a UK responsible person.
Enforcement etc.
Regulation 61
611AIt is the duty of the Secretary of State to enforce these regulations in relation to relevant devices and devices for performance evaluation.1BIt is the duty of each weights and measures authority in Great Britain and each district council in Northern Ireland to enforce these regulations within its area (concurrently with the Secretary of State) in relation to relevant devices that are ordinarily intended for private use or consumption.1CNothing in this regulation authorises a weights and measures authority to bring proceedings in Scotland for an offence.
Compliance notices
Regulation 62
62. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Restriction notices
Regulation 63
63. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Notification of decisions etc.
Regulation 64
64. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Centralised systems of records etc.
Regulation 65
65The Secretary of State shall perform, as respects Northern Ireland, the functions of the Member State under article 8 of Directive 90/385, article 10 of Directive 93/42 and article 11(1) to (3) of Directive 98/79.
Revocations
Regulation 66
66The following provisions are hereby revoked—athe Active Implantable Medical Devices Regulations 1992 ;bthe Medical Devices Regulations 1994 ;cthe Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995 ;dthe Medical Devices Fees Regulations 1995 ;ethe Medical Devices Fees (Amendment) Regulations 1997 ;ftheIn Vitro Diagnostic Medical Devices Regulations 2000 ; andgregulations 6 and 13 of the Medicines (Codification Amendments Etc.) Regulations 2002 .
Review
Regulation 67
67Before the end of 31st December 2025, the Secretary of State must—acarry out a review of these Regulations;bset out the conclusions of the review in a report; andcpublish the report.
SCHEDULE 1 — ASSOCIATION AGREEMENTS
SCHEDULE 1 ASSOCIATION AGREEMENTSRegulation 2(1)1The Agreement establishing an Association between the European Economic Community and Turkey signed at Ankara on 12th September 1963.
SCHEDULE 2 — MUTUAL RECOGNITION AGREEMENTS
SCHEDULE 2 MUTUAL RECOGNITION AGREEMENTSRegulation 2(1)1The agreement on mutual recognition in relation to conformity assessment certificates and markings between the European Community and Australia, initialled on 19th July 1996 .2The agreement on mutual recognition in relation to conformity assessment between the European Union and New Zealand, initialled on 19th July 1996 .3The agreement on mutual recognition between the European Community and Canada, signed in London on 14th May 1998 .4The agreement on mutual recognition between the European Community and the United States of America, signed in London on 18th May 1998 .5The agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment signed in Luxembourg on 21st June 1999.
SCHEDULE 2 — Mutual Recognition Agreement countries
SCHEDULE 2Mutual Recognition Agreement countries Regulation 1A— Australia— New Zealand— Canada— The United States of America— The Swiss Confederation
SCHEDULE 2A — Modification of Annexes to Directives 90/385, 93/42, 98/79
SCHEDULE 2AModification of Annexes to Directives 90/385, 93/42, 98/79 Regulation 1A PART 1Modification of Annexes to Directive 90/38511The Annexes to Directive 90/385 are modified so that they read as if amended by paragraphs 2 to 10.2In this Part any reference to “the Regulations” is a reference to the Medical Devices Regulations 2002.2In Annex 1—zain Section 2, for “the functions referred to in Article 1(2)(a)” substitute “the purposes referred to in the definition of a medical device in regulation 2(1) of the Regulationsain Section 8 for the fifth indent substitute —–risks connected with ionising radiation from radioactive substances included in the device,;bfor Section 10 substitute—10Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in regulation 2 of the Human Medicines Regulations 2012, and which is liable to act upon the body with an action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC as modified by Schedule 8B to the Human Medicines Regulations 2012.For the substances referred to in the first paragraph, the approved body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from the Secretary of State on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing an opinion, the Secretary of State shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the approved body.Where a device incorporates, as an integral part, a human blood derivative, the approved body shall, having verified the usefulness of the substance as part of the device and taking into account the intended purpose of the device, seek a scientific opinion from the Secretary of State on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing the opinion, the Secretary of State shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the approved body.Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the approved body shall be informed of the changes and shall consult the Secretary of State, in order to confirm that the quality and safety of the ancillary substance are maintained. The Secretary of State shall take into account the data related to the usefulness of the incorporation of the substance into the device as determined by the approved body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the device.When the Secretary of State has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance to the device, the Secretary of State shall provide the approved body with advice on whether this information has an impact on the established benefit/risk profile of the addition of the substance to the device or not. The approved body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.;cin Section 14.2 —ifor “the name and address of the authorised representative” substitute “, where such a person is appointed under regulation 21A of the Regulations, the name and address of the UK responsible person,”;iifor “the Community” substitute “the United Kingdom”;iiifor “a device within the meaning of Article 1(4a)” substitute “a stable derivatives devicedin Section 15 in the first indent for “CE mark” substitute “UK mark”.3In Annex 2—afor the heading substitute “Declaration of conformity”;bfor “the notified body” each time it occurs substitute “the approved body”;cfor “this Directive” each time it occurs substitute “the Regulations”;din Section 1, for “EC Surveillance” substitute “Surveillance”;ein Section 2—ifor “his authorized representative” substitute “their UK responsible person”;iiomit “established within the Community”;iiifor “CE marking” , in both places it occurs, substitute “UK marking”;ivfor “Article 12” substitute “regulation 24”;fin Section 3.1—iin the opening words, for “a notified body” substitute “an approved body”;iiomit the fifth indent;gin Section 3.2—iin the first paragraph, omit “of this Directive”;iiin point (c), for “Article 5” substitute “regulation 3A of the Regulations”;hin Section 3.3—ifor the first sentence substitute—The quality system shall be audited by an approved body to determine whether it meets the requirements referred to in Section 3.2.iiin the second sentence for “harmonized” substitute “designated”;iin Section 3.4, in the second paragraph, for the first sentence substitute—The proposed modifications shall be evaluated by the approved body so as to verify whether the quality system so modified would still meet the requirements referred to in Section 3.2.;jin Section 4.2 in the second indent for “Article 5” substitute “regulation 3A of the Regulations”;kfor Section 4.3 substitute—4.3The approved body must examine the application and, where the product complies with the relevant provisions of the Regulations, shall issue the applicant with a design certificate. The approved body may require the application to be supplemented by further tests or proof so that compliance with the requirements of the Regulations may be evaluated. The certificate shall contain conclusions of the examination, the conditions of its validity, the data needed for identification of the approved design and, where appropriate, a description of the intended use of the product.In the case of devices referred to in Annex 1, Section 10, second paragraph, the approved body shall, as regards the aspects referred to in that Section, consult the Secretary of State before taking the decision. The opinion of the Secretary of State shall be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the Secretary of State must be included in the documentation concerning the device. The approved body will give due consideration to the views expressed in this consultation when making its decision. It must convey its final decision to the Secretary of State.In the case of devices referred to in Annex I, Section 10, third paragraph, the scientific opinion of the Secretary of State must be included in the documentation concerning the device. The opinion of the Secretary of State shall be drawn up within 210 days after receipt of valid documentation. The approved body will give due consideration to the opinion of the Secretary of State when making its decision. The approved body may not deliver the certificate if the Secretary of State’s decision is unfavorable. It must convey its final decision to the Secretary of State.;lin Section 4.4, for each reference to “EC design” substitute “design”;min Section 6.1—ifor “national authorities” substitute “Secretary of State”;iifor “his authorised representative” substitute “their UK responsible person”;nfor Section 6.2 substitute—6.2On request, an approved body must make available to other approved bodies and to the Secretary of State all relevant information on approvals of quality systems, issued, refused or withdrawn.;ofor Section 7 substitute—7Application to the devices incorporating a human blood derivative:Upon completing the manufacture of each batch of devices incorporating a human blood derivative, the manufacturer shall inform the approved body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a laboratory provided or arranged in accordance with section 57(1)(d) of the Health and Social Care Act 2012..4In Annex 3—ain the title for “EC TYPE-EXAMINATION” substitute “TYPE-EXAMINATION”;bfor “EC type-examination” in each other place substitute “type-examination”;cfor “a notified body” in each place substitute “an approved body”;dfor “the notified body” in each place substitute “the approved body”;ein Section 1, for “this Directive” substitute “the Regulations”;fin Section 2—ifor the first sentence substitute—The application for type-examination shall be made by the manufacturer to the approved body.;iifor “the authorized representative” substitute “the UK responsible person”;iiifor “this Directive” substitute “the Regulations”;gin Section 3, for each reference to “Article 5” substitute “regulation 3A of the Regulations”;hfor Sections 4 and 5, substitute—4The approved body shall—4.1examine and evaluate the documentation, verify that the type has been manufactured in accordance with that documentation; it shall also record the items which have been designed in accordance with the applicable provisions of the standards referred to in regulation 3A of the Regulations, as well as the items for which the design is not based on the relevant provisions of the said standards.4.2carry out or have carried out the appropriate inspections and the tests necessary to verify whether the solutions adopted by the manufacturer satisfy the essential requirements where the standards referred to in regulation 3A of the Regulations have not been applied.4.3carry out or have carried out the appropriate inspections and the tests necessary to verify whether, where the manufacturer has chosen to apply the relevant standards, these have actually been applied.4.4agree with the applicant on the place where the necessary inspections and tests will be carried out.5Where the type meets the provisions of the Regulations, the approved body shall issue a type-examination certificate to the applicant. The certificate shall contain the name and address of the manufacturer, the conclusions of the control, the conditions under which the certificate is valid and the information necessary for identification of the type approved. The relevant parts of the documentation must be annexed to the certificate and a copy kept by the approved body.In the case of devices referred to in Annex I, Section 10, second paragraph, the approved body shall, as regards the aspects referred to in that Section, consult the Secretary of State before taking the decision. The opinion of the Secretary of State shall be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the Secretary of State must be included in the documentation concerning the device. The approved body will give due consideration to the views expressed in this consultation when making its decision. It must convey its final decision to the Secretary of State.In the case of devices referred to in Annex I, Section 10, third paragraph, the scientific opinion of the Secretary of State must be included in the documentation concerning the device. The opinion of the Secretary of State shall be drawn up within 210 days after receipt of valid documentation. The approved body will give due consideration to the opinion of the Secretary of State when making its decision. The approved body may not deliver the certificate if the Secretary of State’s decision is unfavorable. It must convey its final decision to the Secretary of State.;iin Section 6 omit “EC” each time it occurs;jfor Section 7 substitute—7.1On request, an approved body shall make available to other conformity assessment bodies (including other approved bodies) and to the Secretary of State all relevant information on type-examination certificates and addenda to those certificates issued, refused and withdrawn.7.2The approved body must cooperate with other approved bodies with regard to making available copies of the type examination certificates or addenda to those certificates but, as regards copies of annexes to the certificates, must only make those available to other approved bodies with the consent of the manufacturer.7.3The manufacturer or their UK responsible person shall keep with the technical documentation a copy of the UK type-examination certificates and the supplements to them for a period of at least 15 years from the manufacture of the last product..5For Annex 4 substitute—ANNEX 4VERIFICATION1Verification is the procedure whereby the manufacturer ensures and declares that the products subject to the provisions of Section 3 are in conformity with the type as described in the type-examination certification and satisfy the requirements of the Regulations that apply to them.2The manufacturer shall take all measures necessary in order that the manufacturing process ensures conformity of the products to the type as described in the type-examination certification and to the requirements of the Regulations that apply to them. The manufacturer shall affix the UK marking to each product and draw up a written declaration of conformity.3The manufacturer shall, before the start of manufacture, prepare documents defining the manufacturing processes, in particular as regards sterilization, together with all the routine, pre-established provisions to be implemented to ensure uniformity of production and conformity of the products with the type as described in the type examination certificate as well as with the relevant requirements of the Regulations.4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5The approved body must carry out the appropriate examinations and tests in order to check the conformity of the product to the requirements of the Regulations by examination and testing of products on a statistical basis, as specified in Section 6. The manufacturer must authorize the approved body to evaluate the efficiency of the measures taken pursuant to Section 3, by audit where appropriate.6Statistical verification6.1Manufacturers must present the products manufactured in the form of uniform batches and shall take all necessary measures in order that the manufacturing process ensures the uniformity of each batch produced.6.2A random sample must be taken from each batch. Products in a sample shall be individually examined and appropriate tests, as set out in the standards referred to in regulation 3A of the Regulations, or equivalent tests must be carried out to verify their conformity to the type as described in the type-examination certificate and thereby determine whether a batch is to be accepted or rejected.6.3Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the designated standards referred to in regulation 3A of the Regulations, taking account of the specific nature of the product categories in question.6.4Where batches are accepted, the approved body shall affix, or cause to be affixed, its identification number to each product and draw up a written certificate of conformity relating to the tests carried out. All products in the batch may be placed on the market except for those products from the sample which were found not to be in conformity. Where a batch is rejected, the approved body shall take appropriate measures to prevent the placing on the market of that batch. In the event of frequent rejection of batches the approved body may suspend the statistical verification.The manufacturer may, with the agreement of the approved body, affix the approved body’s identification number during the manufacturing process.6.5The manufacturer or their UK responsible person must ensure that they are able to supply the approved body’s certificates of conformity on request.7Application to the devices incorporating human blood derivative:Upon completing the manufacture of each batch of devices incorporating human blood derivative the manufacturer shall inform the approved body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a laboratory provided or arranged in accordance with section 57(1)(d) of the Health and Social Care Act 2012..6For Annex 5, substitute—ANNEX 5DECLARATION OF CONFORMITY TO TYPE(Assurance of production quality)1The manufacturer shall apply the quality system approved for the manufacture and must conduct the final inspection of the products concerned as specified in Section 3; the manufacturer shall be subject to the surveillance referred to in Section 4.2This declaration of conformity is the procedural element whereby the manufacturer who satisfies the obligations of Section 1 guarantees and declares that the products concerned conform to the type described in the type-examination certificate and meet the provisions of the Regulations which apply to them.The manufacturer must affix the UK marking in accordance with regulation 24 of the Regulations and draw up a written declaration of conformity. This declaration shall cover one or more devices manufactured, clearly identified by means of product name, product code or other unambiguous reference and must be kept by the manufacturer. The UK marking shall be accompanied by the identification number of the approved body responsible.3Quality system3.1The manufacturer shall make an application for evaluation of their quality system to an approved body.The application shall include:all appropriate information concerning the products which it is intended to manufacture,the quality-system documentation,an undertaking to fulfil the obligations arising from the quality system as approved,an undertaking to maintain the approved quality system in such a way that it remains adequate and efficacious,where appropriate, the technical documentation relating to the approved type and a copy of the type-examination certificate,...3.2Application of the quality system must ensure that the products conform to the type described in the type-examination certificate.All the elements, requirements and provisions adopted by the manufacturer for their quality system shall be documented in a systematic and orderly manner in the form of written policies and procedures. This quality-system documentation must make possible a uniform interpretation of the quality policies and procedures such as quality programmes, quality plans, quality manuals and quality records. It shall include in particular an adequate description of—athe manufacturer’s quality objectives;bthe organization of the business and in particular—the organizational structures, the responsibilities of the managerial staff and their organizational authority where manufacture of the products is concerned,methods of monitoring the efficient operation of the quality system and in particular its ability to achieve the desired quality of the products, including control of products which do not conform,where the manufacture and/or final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;cthe techniques of control and of quality assurance at the manufacturing stage and in particular—the processes and procedures which will be used, particularly as regards sterilization, purchasing and the relevant documents,product identification procedures drawn up and kept up-to-date from drawings, specifications or other relevant documents at every stage of manufacture;dthe appropriate tests and trials which will be effected before, during and after production, the frequency with which they will take place, and the test equipment used.3.3Without prejudice to regulation 50 of the Regulations, the approved body shall effect an audit of the quality system to determine whether it meets the requirements referred to in Section 3.2. It shall presume conformity with these requirements for the quality systems which use the corresponding harmonized standards.The team entrusted with the evaluation shall include at least one member who has already had experience of evaluations of the technology concerned. The evaluation procedure shall include an inspection on the manufacturer’s premises.The decision shall be notified to the manufacturer after the final inspection. It shall contain the conclusions of the control and a reasoned evaluation.3.4The manufacturer shall inform the approved body which has approved the quality system of any plan to alter that system.The approved body shall evaluate the proposed modifications and shall verify whether the quality system so modified would meet the requirements referred to in Section 3.2; it shall notify the manufacturer of its decision. This decision shall contain the conclusions of the control and a reasoned evaluation.4Surveillance4.1The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations which arise from the approved quality system.4.2The manufacturer shall authorize the approved body to carry out all necessary inspections and shall supply it with all appropriate information, in particular—the quality-system documentation,the technical documentation,the data stipulated in the part of the quality system relating to manufacture, such as reports concerning inspections, tests, standardizations/ calibrations and the qualifications of the staff concerned, etc.4.3The approved body must periodically carry out appropriate inspections and evaluations in order to ascertain that the manufacturer is applying the approved quality system, and shall supply the manufacturer with an evaluation report.4.4In addition, the approved body may make unannounced visits to the manufacturer, and must supply the manufacturer with an inspection report.5The approved body shall communicate to the other approved bodies all relevant information concerning approvals of quality systems issued, refused or withdrawn.6Application to the devices incorporating human blood derivative:Upon completing the manufacture of each batch of devices, incorporating human blood derivative, the manufacturer shall inform the approved body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a laboratory provided or arranged in accordance with section 57(1)(d) of the Health and Social Care Act 2012..7In Annex 6—ain Section 1, for “authorised representative established within the Community” substitute “UK responsible person”;bin Section 3 for “the competent national authorities” substitute “the Secretary of State”;cin Section 3.1 for “this Directive” substitute “the Regulations”;din Section 3.2 for the fourth indent substitute—–the results of the risk analysis and a list of the designated standards provided for in regulation 3A of the Regulations, applied in full or in part, and a description of the solutions adopted to satisfy the essential requirements where the standards in regulation 3A of the Regulations have not been applied,;eomit Section 5.8In Annex 7—ain Section 1.1 for “harmonised” substitute “designated”;bin Section 2.3.5 for “all competent authorities of the Member States in which the clinical investigation is being performed” substitute “the Secretary of State”;9In Annex 8—ain the title for “when designating inspection bodies to be notified” substitute “when designating approved bodies”;aain Section 1 for “authorized representative” substitute “UK responsible person”;bin Section 3 omit the words “and for which it has been notified”;cin Section 6 omit from “unless liability” to the end;din Section 7 omit from “(except vis-à-vis” to the end.10Omit Annex 9.PART 2Modification of Annexes to Directive 93/42111The Annexes to Directive 93/42 are modified so that they read as if amended by paragraphs 12 to 23.2In this Part any reference to “the Regulations” is a reference to the Medical Devices Regulations 2002.12In Annex I—ain Section 3, for “Article 1(2)(a)” substitute “regulation 2(1) of the Regulations”;bin Section 7, for “notified body” each time it occurs substitute “approved body”;cfor Section 7.4, substitute—7.4Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in regulation 2 of the Human Medicines Regulations 2012, and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I toDirective 2001/83/ECas modified by the Human Medicines Regulations 2012.For the substances referred to in the first paragraph, the approved body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from the Secretary of State on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing an opinion, the Secretary of State shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the approved body.Where a device incorporates, as an integral part, a human blood derivative, the approved body shall, having verified the usefulness of the substance as part of the medical device and taking into account the intended purpose of the device, seek a scientific opinion from the Secretary of State on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing the opinion, the Secretary of State shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the approved body.Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the approved body must be informed of the changes and must consult the Secretary of State in order to confirm that the quality and safety of the ancillary substance are maintained. The Secretary of State must take account of the data related to the usefulness of incorporation of the substance into the device as determined by the approved body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the medical device.When the Secretary of State has obtained information on an ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance to the device, the Secretary of State must provide the approved body with advice on whether this information has any impact on the established benefit/risk profile of the addition of the substance in the medical device or not. The approved body must take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.;din Section 7.5—ifor the reference to “Annex 1 to Council Directive 67/548/EEC of 27 June 1967”, substitute “Regulation (EC) No. 1272/2008”;iifor the reference to “Annex 1 to Council Directive 67/548/EEC”, substitute “the UK mandatory classification and labelling list established and maintained in accordance with Article 38A of Regulation 1272/2008”;ein Section 10.3 for “the provisions of Council Directive 80/181/EEC” substitute “the Units of Measurement Regulations 1986”;fin Section 13.3—iin point (a) —aafor the first two references to “the Community” substitute “Great Britain”;bbfor the third reference to “the Community” substitute “the United Kingdom”;ccfor “the authorised representative” substitute “the UK responsible person (where appointed in accordance with regulation 7A of the Regulations)”;iiin point (f) omit the second sentence;iiiin point (n) omit “in the case of a device within the meaning of Article 1(4a),”.13In Annex II—ain the title omit “EC”;bfor each reference to “the notified body” substitute “the approved body”;cin Section 1 omit “Community”;din Section 2—iomit “EC”;iifor “this Directive” substitute “the Regulations”;iiifor “CE marking” substitute “UK marking”;ivomit the words “in accordance with Article 17”;dain Section 3.1—iin the first sentence, for “a notified body” substitute “an approved body”;iifor “other notified body” substitute “other approved body”;iii. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .ivomit the seventh indent;ein Section 3.2—iin the first paragraph for “this Directive” substitute “the Regulations”iiin point (c)—aafor “Article 5” substitute “regulation 3A of the Regulations”;bbfor “Commission Directive 2003/32/EC” substitute “Commission Regulation 722/2012”;ffor Section 3.3 substitute—3.3The approved body must audit the quality system to determine whether it meets the requirements referred to in Section 3.2. It must presume that quality systems which implement the relevant designated standards conform to these requirements.The assessment team must include at least one member with past experience of assessments of the technology concerned. The assessment procedure must include an assessment, on a representative basis, of the documentation of the design of the product concerned, an inspection on the manufacturer’s premises and, in duly substantiated cases, on the premises of the manufacturer’s suppliers and/or subcontractors to inspect the manufacturing processes.The decision must be notified to the manufacturer. It must contain the conclusions of the inspection and a reasoned assessment..gfor Section 3.4 substitute—3.4The manufacturer must inform the approved body which approved the quality system of any plan for substantial changes to the quality system or the product-range covered. The approved body must assess the changes proposed and verify whether after these changes the quality system still meets the requirements referred to in Section 3.2. It must notify the manufacturer of its decision. This decision must contain the conclusions of the inspection and a reasoned assessment.;hin Section 4.2, for “this Directive” substitute “the Regulations”;ifor Section 4.3 substitute—4.3The approved body must examine the application and, where the product complies with the relevant provisions of the Regulations, must issue the applicant with a design certificate. The approved body may require the application to be supplemented by further tests or proof so that compliance with the requirement of the Regulations may be evaluated. The certificate must contain conclusions of the examination, the conditions of its validity, the data needed for identification of the approved design and, where appropriate, a description of the intended use of the product.In the case of devices referred to in Annex 1, Section 7.4, second paragraph, the approved body must, as regards the aspects referred to in that Section, consult the Secretary of State before taking the decision. The opinion of the Secretary of State must be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the Secretary of State must be included in the documentation concerning the device. The approved body will give due consideration to the views expressed in this consultation when making its decision. It must convey its final decision to the Secretary of State.In the case of devices referred to in Annex I, Section 7.4, third paragraph, the scientific opinion of the Secretary of State must be included in the documentation concerning the device. The opinion of the Secretary of State must be drawn up within 210 days after receipt of valid documentation. The approved body will give due consideration to the opinion of the Secretary of State when making its decision. The approved body may not deliver the certificate if the Secretary of State’s decision is unfavorable. It must convey its final decision to the Secretary of State.;jin Section 4.4, omit each reference to “EC”;kin Section 6.1—ifor “authorised representative” substitute “UK responsible person”;iifor “national authorities” substitute “Secretary of State”;lin Section 7.1 for “Article 11(2) and (3)” substitute “regulation 13(2) and (3) of the Regulations”;min Section 7.2 omit “for compliance with the provisions of this Directive”;nin Section 7.3 omit “for compliance with the provisions of this Directive”;oin Section 7.4 —ifor “this Directive” substitute “the Regulations”;iifor “the competent authority” substitute “the Secretary of State”;pfor Section 8, substitute—8Application to the devices incorporating a human blood derivativeUpon completing the manufacture of each batch of devices incorporating a human blood derivative, the manufacturer shall inform the approved body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a laboratory provided or arranged in accordance with section 57(1)(d) of the Health and Social Care Act 2012..14In Annex III—afor each reference to “EC type-examination” (including in the title), substitute “type-examination”;bin Section 1—ifor “a notified body” substitute “an approved body”;iifor “this Directive” substitute “the Regulations”;cin Section 2—iin the first indent,—aafor “authorized representative” substitute “UK responsible person” ;bbfor “the representative” substitute “the UK responsible person”;iiin the second indent, for the second and third sentences substitute—The applicant must provide samples at the request of the approved body.;iiiin the third indent, for “notified” substitute “approved”;din Section 3—ifor each reference to “Article 5” substitute “regulation 3A of these Regulations”;iifor “Directive 2003/32/EC” substitute “Commission Regulation 722/2012”;efor Sections 4 and 5 substitute—4The approved body must—4.1examine and assess the documentation, verify that the type has been manufactured in accordance with that documentation; it must also record the items which have been designed in accordance with the applicable provisions of the standards referred to in regulation 3A of the Regulations, as well as the items for which the design is not based on the relevant provisions of the said standards;4.2carry out or arrange for the appropriate inspections and the tests necessary to verify whether the solutions adopted by the manufacturer satisfy the essential requirements of the Regulations where the standards referred to in regulation 3A of the Regulations have not been applied; if the device is to be connected to another device or other devices in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device having the characteristics specified by the manufacturer;4.3carry out or arrange for the appropriate inspections and the tests necessary to verify whether, where the manufacturer has chosen to apply the relevant standards, these have actually been applied;4.4agree with the applicant on the place where the necessary inspections and tests will be carried out.5Where the type meets the provisions of the Regulations, the approved body must issue a type-examination certificate to the applicant. The certificate must contain the name and address of the manufacturer, the conclusions of the inspection, the conditions under which the certificate is valid and the information necessary for identification of the type approved. The relevant parts of the documentation must be annexed to the certificate and a copy kept by the approved body.In the case of devices referred to in Annex I, Section 7.4, second paragraph, the approved body must, as regards the aspects referred to in that Section, consult the Secretary of State before taking the decision. The opinion of the Secretary of State must be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the Secretary of State must be included in the documentation concerning the device. The approved body must give due consideration to the views expressed in this consultation when making its decision. It must convey its final decision to the Secretary of State.In the case of devices referred to in Annex I, Section 7.4, third paragraph, the scientific opinion of the Secretary of State must be included in the documentation concerning the device. The opinion of the Secretary of State must be drawn up within 210 days after receipt of valid documentation. The approved body will give due consideration to the opinion of the Secretary of State when making its decision. The approved body may not deliver the certificate if the Secretary of State’s decision is unfavorable. It must convey its final decision to the Secretary of State.In the case of devices manufactured utilizing tissues of animal origin referred to in Commission Regulation 722/2012, the approved body must follow the procedures referred to in that Regulation.;fin Section 6—ifor each reference to “notified body” substitute “approved body”;iiomit each reference to “EC”;gfor Section 7.2 substitute—7.2An approved body must cooperate with other approved bodies with regard to making available copies of the type-examination certificates or addenda to those certificates but, as regards copies of annexes to the certificates, must only make those available to other approved bodies with the consent of the manufacturer..hin Section 7.3 —ifor “authorised representative” substitute “UK responsible person”;iiomit “EC”.15In Annex IV—aomit “EC” (including in the title) each time it occurs;bfor both references to “this Directive” substitute “the Regulations”;cfor each reference to “the Directive” substitute “the Regulations”;din Section 1 for “authorized representative” substitute “UK responsible person”;ein Section 2—ifor “CE marking” substitute “UK marking”;iifor “Article 17” substitute “regulation 10 of the Regulations”;fomit Section 3;gfor Sections 4 to 6 substitute—4The approved body must carry out the appropriate examinations and tests in order to verify the conformity of the product with the requirements of the Regulations either by examining and testing every product as specified in Section 5 or by examining and testing products on a statistical basis as specified in Section 6, as the manufacturer decides.The aforementioned checks do not apply to those aspects of the manufacturing process designed to secure sterility.5Verification by examination and testing of every product5.1Every product must be examined individually and the appropriate tests defined in the relevant standards referred to in regulation 3A of the Regulations must be carried out in order to verify, where appropriate, the conformity of the products with the type described in the type-examination certificate and with the requirements of the Regulations which apply to them.5.2The approved body must affix, or have affixed its identification number to each approved product and must draw up a written certificate of conformity relating to the tests carried out.6Statistical verification6.1The manufacturer must present the manufactured products in the form of homogeneous batches.6.2A random sample must be taken from each batch. The products which make up the sample are examined individually and the appropriate tests defined in the relevant standards referred to in regulation 3A of the Regulations or equivalent tests must be carried out to verify, where appropriate, the conformity of the products with the type described in the type-examination certificate and with the requirements of the Regulations which apply to them in order to determine whether to accept or reject the batch.6.3Statistical control of products will be based on attributes and/or variables entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the designated standards referred to in regulation 3A of the Regulations, taking account of the specific nature of the product categories in question.6.4If the batch is accepted, the approved body affixes or has affixed its identification number to each product and draws up a written certificate of conformity relating to the tests carried out. All products in the batch may be put on the market except any in the sample which failed to conform.If a batch is rejected, the approved body must take appropriate measures to prevent the batch from being placed on the market. In the event of frequent rejection of batches, the approved body may suspend the statistical verification.The manufacturer may, on the responsibility of the approved body, affix the approved body’s identification number during the manufacturing process.;hin Section 7—ifor “authorised representative” substitute “UK responsible person”;iifor “national authorities” substitute “Secretary of State”;iin Section 8, in the opening paragraph, for “Article 11(2)” substitute “regulation 13(2) of the Regulations”;zjin Section 8.2 for “notified body” substitute “approved body”;jin Section 9—ifor the words “referred to in Article 1(4a)” substitute “which incorporate a substance derived from human blood or human plasma”;iafor “notified body” substitute “approved body”;iifor the words from “a State laboratory” to the end of that Section, substitute “a laboratory provided or arranged in accordance with section 57(1)(d) of the Health and Social Care Act 2012”.16In Annex V—afor “notified body” each time it occurs substitute “approved body”;bomit “EC” each time it occurs, including in the title;cin Section 1, omit “Community”;din Section 2—ifor “this Directive” substitute “the Regulations”;iifor “CE marking in accordance with Article 17” substitute “UK marking”;eomit the eighth indent of Section 3.1;fin Section 3.3, for the first sentence substitute—The quality system must be audited by the approved body to determine whether it meets the requirements referred to in Section 3.2.;gin Section 3.4, for the last two paragraphs substitute—The proposed changes must be evaluated by the approved body so as to verify whether the quality system after these changes would still meet the requirements referred to in Section 3.2.;hin Section 5.1—ifor “authorised representative” substitute “UK responsible person”;iifor “national authorities” substitute “Secretary of State”;iin Section 6 for each reference to “this Directive” substitute “the Regulations”;jin Section 6.3, for “competent authority” substitute “Secretary of State”;kin Section 7—ifor the words “referred to in Article 1(4a)” substitute “which incorporate a substance derived from human blood or human plasma”;iifor the words from “a State laboratory” to the end of that Section, substitute “a laboratory provided or arranged in accordance with section 57(1)(d) of the Health and Social Care Act 2012.”.17In Annex VI—aomit “EC” each time it occurs including in the title;bfor “the notified body” each time it occurs substitute “the approved body”;cfor “this Directive” each time it occurs substitute “the Regulations”;din Section 2—ifor “CE marking in accordance with Article 17” substitute “UK marking”;iifor “CE marking must” substitute “UK marking must”;ein Section 3.1–ifor “a notified body” substitute “an approved body”;iifor “other notified body” substitute “other approved body”;iiiomit the eighth indent;fin Section 3.3, for the first sentence substitute—The quality system must be audited by the approved body to determine whether it meets the requirements referred to in Section 3.2.;gin Section 3.4, for the second paragraph substitute—The proposed changes must be assessed by the approved body so as to verify whether the quality system after these changes would still meet the requirements referred to in Section 3.2.;gain Section 4.4 for “Article 5” substitute “regulation 3A of the Regulations”;hin Section 5.1—ifor “authorised representative” substitute “UK responsible person”;iifor “national authorities” substitute “Secretary of State”;iin Section 6, in the opening paragraph, for “Article 11(2)” substitute “regulation 13(2) of the Regulations”;jin Section 6.3, for “competent authority” substitute “Secretary of State”.kin Section 6.4 for “notified body” substitute “approved body”.18In Annex VII—ain the title and in Section 1, omit “EC”;bin Section 1—ifor “authorised representative” substitute “UK responsible person”;iifor “this Directive” substitute “the Regulations”;cin Section 2 for—i“his authorised representative” substitute “the manufacturer’s UK responsible person”;ii“national authorities” substitute “Secretary of State”;din Section 3—iin the opening paragraph for “the Directive” substitute “the Regulations”;iiin the fourth indent—aafor “Article 5” in both places it occurs substitute “regulation 3A of the Regulations”;bbfor “of the Directive” substitute “in Annex I”;eomit Section 4;fin Section 5, for “the intervention by the notified body” substitute “the intervention by the approved body”;gin Section 6, in the opening paragraph, for “Article 11(2)” substitute “regulation 13(2) of the Regulations”.19In Annex VIII—ain Section 1, for “authorized representative” substitute “UK responsible person”;bin Section 2.2 in the seventh indent for “Directive 2003/32/EC” substitute “Regulation 722/2012”;cin Section 3, for “competent national authorities” substitute “Secretary of State”;din Sections 3.1 and 3.2, for “this Directive” each time it occurs substitute “the Regulations”;ein Section 3.2—iin the fourth indent, for “Article 5” in both places it occurs substitute “regulation 3A of the Regulations”;iiin the sixth indent, for “Directive 2003/32/EC” substitute “Regulation 722/2012”;fomit Section 5.20In Annex IX for “this Directive” each time it occurs substitute “the Regulations”.21In Annex X—ain Section 1.1 for “harmonised standards” substitute “designated standards”;bin Section 2.3.5 for the words from “all competent authorities of the Member States” to the end substitute “the Secretary of State”.22In Annex X1—ain the title, for “notified bodies” substitute “approved bodies”;bfor the words “notified body” each time they occur substitute “approved body”;cfor each reference to “the Directive” substitute “the Regulations”;din Section 2, for “national authorities” substitute “Secretary of State”;ein Section 3, for “this Directive” substitute “the Regulations”;fin Section 6, omit the words from “, unless liability” to the end of that Section;gin Section 7, omit the words from “(except vis a vis the competent administrative authorities” to the end.23Omit Annex XII.PART 3Modification of Annexes to Directive 98/79241The Annexes to Directive 98/79 are modified so that they read as if amended by paragraphs 25 to 33.2In this Part any reference to “the Regulations” is a reference to the Medical Devices Regulations 2002.25In Annex 1—ain Section 3 in part A, for “Article 1(2)(b)” substitute “regulation 2(1) of the Regulations”;bin Section 4.2 in part B, for “Council Directive 80/181/EEC of 20th December 1979” substitute “the Units of Measurement Regulations 1986”;cin Section 8.1 in part B, omit the words from “The decision whether” to the end;din Section 8.2 in part B, for “harmonised standards” substitute “designated standards”;ein Section 8.3 in part B —iin the first sentence omit “of Directive 67/548/EEC and Directive 88/379/EEC”;iiin the second sentence omit “by those Directives”;iiiomit the words from “The provisions of” to the end;fin Section 8.4 in point (a), for the sentence beginning “For devices imported”, substitute—Where the manufacturer does not have a registered place of business in the United Kingdom the label, the outer packaging or instructions for use shall contain in addition the name and address of the UK responsible person..26In Annex III—ain the title and in Section 1, omit “EC”;bin Section 1—ifor “authorised representative” substitute “UK responsible person”;iifor “this Directive” substitute “the Regulations”;iiifor “CE marking in accordance with Article 16” substitute “UK marking in accordance with regulation 36 of the Regulations”;cin Section 3, for “the Directive” in both places substitute “the Regulations”;din Section 3, in the sixth indent, for “Article 5” in both places substitute “regulation 3A of the Regulations”;eomit Section 5;fin Section 6, for “a notified body” substitute “an approved body”;gin Section 6.2—ifor “notified body”, both times those words occur, substitute “approved body”;iiin the first sentence, for “this Directive” substitute “the Regulations”;iiiin the second sentence omit “of the Directive”;ivfor “an EC” substitute “a” ;hin Section 6.3—ifor “notified body” in both places substitute “approved body”;iiomit each reference to “EC”;iiifor “the Directive” substitute “the Regulations”.27In Annex IV—ain the title, omit “EC”;bfor each reference to “this Directive” and “the Directive” substitute “the Regulations”;cin Section 2, for “CE marking” substitute “UK marking”;din Section 3.1—ifor “of his quality system with a notified body” substitute “of its quality system with an approved body”;iiin the third indent for “notified body” substitute “approved body”;iiiomit the final indent;ein Section 3.3 for the first paragraph substitute—The quality system must be audited by the approved body to determine whether it meets the requirements referred to in Section 3.2. It must presume that quality systems which implement the relevant designated standards conform to the requirements.;fin Section 3.4, in both paragraphs, for “notified body” substitute “approved body”;gin Section 4.1 for “notified body” substitute “approved body”;hin Section 4.3—ifor “notified body” both times those words occur substitute “approved body”;iifor “an EC” substitute “a”;iin Section 4.4—ifor “notified body” both times those words occur substitute “approved body”;iiomit each reference to “EC”;jin Section 4.5, for “notified body” both times those words occur substitute “approved body”;kin Sections 5 and 6 for “notified body” each time those words occur substitute “approved body”.28In Annex V—ain the title, omit “EC” ;bin Section 1—ifor “EC type-examination” substitute “Type-examination”;iifor “a notified body” substitute “an approved body”;iiifor “this Directive” substitute “the Regulations”;cin Section 2—iin the first paragraph—aa omit “EC”;bbfor “his authorised representative” substitute “its UK responsible person”;ccfor “a notified body” substitute “an approved body”;iiin the first indent—aafor “authorised representative” substitute “UK responsible person”;bbfor “the representative” substitute “the UK responsible person”;iiiin the second indent for “this Directive” substitute “the Regulations”;ivin the second and third indents for “notified body” each time those words occur substitute “approved body”;din Section 4—ifor “notified body shall” substitute “approved body must”;iifor both references to “Article 5” substitute “regulation 3A of the Regulations”;iiifor “this Directive” substitute “the Regulations”;ein Section 5—ifor “this Directive” substitute “the Regulations”;iifor “notified body” in both places substitute “approved body”;iiifor “an EC” substitute “a”;fin Section 6—ifor “notified body” each time it occurs substitute “approved body”;iiomit “EC” each time it occurs;iiifor “the Directive” substitute “the Regulations”;gfor Section 7, substitute—7An approved body must cooperate with other approved bodies with regard to making available copies of the type-examination certificates or addenda to those certificates but, as regards copies of annexes to the certificates, must only make those available to other approved bodies with the consent of the manufacturer..29In Annex VI—ain the title omit “EC”;bin Section 1—ifor “EC verification” substitute “Verification”;iifor “authorised representative” substitute “UK responsible person”;iiifor “EC type-examination” substitute “type-examination”;ivfor “this Directive” substitute “the Regulations”;cin Section 2.1—ifor “EC type-examination” in both places substitute “type-examination”;iifor “the Directive” substitute “the Regulations”;iiifor “this Directive” substitute “the Regulations”;din Section 2.2 for “notified body” substitute “approved body”;daomit Section 3;ein Section 4—ifor “notified body” in both places substitute “approved body”;iifor “the Directive” substitute “the Regulations”;fin Section 5.1—ifor “Article 5” substitute “regulation 3A of the Regulations”;iiomit “EC”;iiifor “the Directive” substitute “the Regulations”;gin Section 5.2 for “notified body” substitute “approved body”;hin Section 6.2—ifor “Article 5” substitute “regulation 3A of the Regulations”;iiomit “EC”;iiifor “the Directive” substitute “the Regulations”;iin Section 6.3 for “the harmonised standards referred to in Article 5” substitute “the designated standards referred to in regulation 3A of the Regulations”;jin Section 6.4—ifor the first two paragraphs, substitute—Where the approved body has drawn up a written certificate of conformity in relation to a batch, all products in that batch to which that body has affixed, or caused to be affixed, an identification number may be placed on the market.;iiin the third paragraph, for “notified body”, in both places, substitute “approved body”.30In Annex VII—ain the title and in Section 2, omit “EC”;bin Section 2—ifor “this Directive” substitute “the Regulations”;iifor “CE marking in accordance with Article 16” substitute “UK marking in accordance with regulation 36 of the Regulations”;cin Section 3.1—ifor “a notified body” substitute “an approved body”;iifor “EC type-examination” substitute “type-examination”;din Section 3.2, for “EC type-examination” substitute “type-examination”;ein Section 3.3 for the first two sentences substitute—The quality system must be audited by the approved body to determine whether it meets the requirements referred to in Section 3.2. The approved body must presume that quality systems which implement the relevant designated standards conform to the requirements.;fin Section 3.4—ifor “notified body” substitute “approved body”;iifor the first sentence of the second paragraph substitute “The proposed changes must be assessed by the approved body so as to verify whether the quality system after these changes would meet the requirements referred to in Section 3.2.”;gin Sections 5.1 and 5.2, for each reference to “notified body” substitute “approved body”.31In Annex VIII—ain Section 1—ifor “authorised representative” substitute “UK responsible person”;iifor “this Directive” substitute “the Regulations”;bin Section 2, for “the Directive” substitute “the Regulations”;cin Section 3—ifor “competent national authorities” substitute “Secretary of State”;iifor “this Directive” substitute “the Regulations”.32In Annex IX—ain the title, for “notified bodies” substitute “approved bodies”;bfor each reference to “notified body” substitute “approved body”;cin Section 1, for “authorised representative” substitute “UK responsible person”;din Section 2—ifor “the Directive” substitute “the Regulations”;iifor “national authorities” substitute “Secretary of State”;iiifor “this Directive” substitute “the Regulations”;ein Section 3—ifor “has been notified” substitute “has been designated”;iifor “this Directive” substitute “the Regulations”;fin Section 6, omit the words from “unless liability” to the end;gin Section 7, omit the words from “(except vis à vis the competent administrative authorities” to the end.33Omit Annex X.