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Medicines Authority · structured requirements

🇲🇹 Malta medical device regulatory data

Explore the medical device requirements currently available for Malta, organized by topic and linked to official sources.

34 facts25 dimensions15 official sourceslatest verification 2026-09-16

Advertising, claims & promotion

Which claims, audiences, channels, approvals, and restrictions apply?

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Advertising and claims for medical devices in Malta

advertising.mdr-article-7-plus-consumer-affairs-act-no-device-instrument
Fact-level verified

Advertising of, and claims for, medical devices in Malta are governed directly by Article 7 of Regulation (EU) 2017/745, which prohibits the use of text, names, trade marks, pictures and figurative or other signs that may mislead the user or the patient as to the device's intended purpose, safety and performance in the labelling, instructions for use, making available, putting into service and advertising of devices. Malta has adopted no device-specific advertising instrument: the Medical Devices and In-Vitro Diagnostic Medical Devices Provision on the Maltese Market Regulations (S.L. 458.59), which is the whole of the Maltese device provision regime and runs to eleven regulations, contains no advertising provision at all, and the advertising controls of the Medicines Act (Cap. 458) are confined to medicinal products. Advertising of devices outside the device framework falls under the general misleading-advertising rule of the Consumer Affairs Act (Cap. 378): unfair commercial practices are prohibited, a commercial practice is unfair if it is misleading under Article 51C or 51D, and "commercial practice" is defined to include any "commercial communication including advertising and marketing" by a trader directly connected with the promotion, sale or supply of a product to consumers, "product" being any good or service — so a misleading advertisement for a device is caught by that general regime as well as by Article 7.

Conditions
  • The operative rule is Union law: MDR Article 7 applies directly in Malta as a Member State, and its four prohibited misleading effects (points (a) to (d)) need no national transposition.
  • S.L. 458.59 contains no advertising provision — verified by reading the instrument in full (citation, interpretation, designation of the competent authority, administration, importation/wholesaling/manufacturing/re-purposing, medical device registered person, issuing of approval, guidelines, monitoring and review, complaints, fines) — so no Maltese device-specific advertising rule exists to record.
  • The Medicines Act advertising provisions (Article 31, under the marginal note "Advertising of medicinal products": "A medicinal product may only be advertised in accordance with such conditions as may be established by or under this Act.") are drafted for and confined to medicinal products; Article 111 of the same Act is what carries the device regulations into that Act, and it does so by deeming regulations issued under the Product Safety Act to have been issued under the Medicines Act, not by extending the medicinal-product advertising controls to devices.
  • The Consumer Affairs Act layer is consumer-facing and general: it is not device-specific, it does not reproduce MDR Article 7, and it operates through the Director General (Consumer Affairs) and the Consumer Claims Tribunal rather than through the Medicines Authority.

Effective from 2021-05-26

Medical Devices and In-Vitro Diagnostic Medical Devices Provision on the Maltese Market Regulations (S.L. 458.59), Legal Notice 321 of 2020Consumer Affairs Act (Cap. 378) — Article 51B (unfair commercial practices prohibited), Articles 51C and 51D (misleading actions and misleading omissions) and the definitions of "commercial practice" and "product"

Union layer, read on 2026-09-16 in the consolidated text of Regulation (EU) 2017/745 cited as the source (CELEX 02017R0745-20230320). Quoted exactly as the consolidated text prints it: "trade marks" with a space, and the consolidator's corrigendum markers ("►C1 ... ◄") removed from the quotation; the Official Journal text of 5.5.2017 prints "trademarks" and is otherwise identical, and Article 7 has not been amended since publication. Date of application: Article 123(2) was amended by Article 1(a) of Regulation (EU) 2020/561, which provides verbatim "Article 123 is amended as follows: (a) in paragraph 2, the date '26 May 2020' is replaced by '26 May 2021'"; hence effectiveFrom 2026-09-16 rests on 2021-05-26 as the date from which the MDR applies. National layer, negative limb, verbatim from S.L. 458.59 (L.N. 321 of 2020, 4th August 2020), read in full: the instrument's eleven regulations are "1. The title of these regulations is the Medical Devices and In-Vitro diagnostic Medical Devices Provision on the Maltese Market Regulations.", regulation 2 (Interpretation), "3. The competent authority is designated under these regulations: (a) as the authority in charge of regulating and ensuring compliance and adherence to the applicable local and international laws that apply to medical devices; and (b) as the authority responsible for designation and supervision of notified bodies concerned with medical devices in Malta.", regulation 4 (Administration), "5. (1) No person shall carry out importation, wholesaling, manufacturing or re-purposing in Malta of any medical device which is intended for trade within the European Union and, or the local market prior to obtaining all the necessary approvals, authorisations, licences, permits and, or any notification/s as required by or under these regulations or any other law." (with sub-regulation (2)(a)-(g), including "(f) have a medical device registered person in Malta;" and "(g) insert details of all medical devices which he markets locally in the national medical device database kept by the competent authority."), regulation 6 (Obligation for medical device registered person), regulation 7 (Issuing of approval), regulation 8 (Issue of guidelines), regulation 9 (Monitoring and review of operations), regulation 10 (Obligation of economic operators to transmit complaints to competent authority) and "11. Any person who contravenes any provision of these regulations shall be guilty of an offence and shall on conviction be subject to a fine (multa) of not less than twelve thousand euro (€12,000) and not exceeding one hundred and twenty thousand euro (€120,000) or to imprisonment for a term not exceeding two (2) years, or to both such fine and imprisonment." A whole-text search of that instrument returns zero occurrences of "advertis" and zero of "misleading"; the only two occurrences of "review" are the heading "Monitoring and review of operations" and its text. The Medicines Act limb: Article 111 ("Medical devices and in vitro diagnostic medical devices. Any regulations issued under the Product Safety Act dealing with medical devices and in vitro diagnostic medical devices shall be deemed to have been issued under this Act.", added by Act XXXV.2020.2, cross-referring Cap. 427) is the bridge by which S.L. 458.59 hangs off Cap. 458, and it does not extend the Act's medicinal-product advertising provisions to devices; Article 31 itself reads, verbatim and under the marginal note "Advertising of medicinal products", "A medicinal product may only be advertised in accordance with such conditions as may be established by or under this Act.", and Article 29 (power to make regulations) lists at paragraph (g) "advertising in respect of medicinal products, and the presentation and information contained in the advert", confirming the Act's advertising competence is drafted for medicinal products. Provenance of the Maltese texts quoted in this fact: each was read on 2026-09-16 in the PDF served by legislation.mt for the instrument cited — the site's viewer endpoint /getpdf/<id>, linked from the /eli/... landing page recorded as the source URL — extracted with pdftotext -layout. National layer, positive limb, verbatim from the Consumer Affairs Act (Cap. 378), as amended up to Legal Notice 212 of 2023: "51B. (1) Unfair commercial practices shall be prohibited."; "(3) In particular, a commercial practice shall be unfair if it is misleading in terms of articles 51C and 51D, or aggressive in terms of article 51E."; "51C. A commercial practice shall be regarded as misleading if: (a) it contains false information; or (b) in any way, including its overall presentation, deceives or is likely to deceive the average consumer, even if the information is factually correct ..."; "51D. (1) A commercial practice shall be regarded as misleading if: (a) in its factual context, taking account of all its features and circumstances and the limitations of the communication medium, it omits material information that the average consumer needs, according to the context, to take an informed transactional decision and thereby causes or is likely to cause the average consumer to take a transactional decision that he would not have taken otherwise ..."; and the two definitions that make a device advertisement fall inside this Title: "'commercial practice' means any act, omission, course of conduct or representation, commercial communication including advertising and marketing, by a trader, directly connected with the promotion, sale or supply of a product to consumers; whether it takes place before, during or after a commercial transaction in relation to the product;" and "'product' means any good or service including immovable property, digital service and digital content, as well as rights and obligations;". What was NOT found, and is therefore not asserted: no Maltese measure penalising misleading advertising of a medical device specifically, and no guidance from the Medicines Authority on advertising or claims for devices — the Authority's Medical Devices Forms index (read on 2026-09-16) carries forms for organisation registration, revision or withdrawal, notification, non-CE-marked use, incident reporting, clinical investigations and risk classification, but no advertising or claims procedure.

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

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CE certificate validity (5 years max) and the MDR transition dates as at 2026-09-15

validity.ce-certificate-five-year-maximum-and-2023-607-transition
Fact-level verified

The substantive term of a device's approval is the CE certificate: a notified-body certificate is valid for the period it indicates, which may not exceed five years, and may be extended for further periods of up to five years each on re-assessment. Directive-era certificates are governed by the transitional regime as amended by Regulation (EU) 2023/607: certificates issued under Directive 90/385/EEC or 93/42/EEC from 25 May 2017 that were still valid on 26 May 2021 remain valid until 31 December 2027 for class III devices and class IIb implantable devices, and until 31 December 2028 for other class IIb devices, class IIa devices and class I devices placed on the market sterile or with a measuring function. As at 15 September 2026 the extended dates are still in the future and no further extension has been adopted.

Conditions
  • The transitional validity is conditional, including a quality management system in place by 26 May 2024 and a notified-body agreement, and no significant changes in design or intended purpose (MDR Art. 120(3c)).
  • Devices whose Directive-era conformity assessment did not involve a notified body but which require one under the MDR may be placed on the market until 31 December 2028 (MDR Art. 120(3b)).
  • Maltese national registrations run alongside and renew annually on their own cycle.

Effective from 2023-03-20

Verbatim from the amending Regulation: '(a) 31 December 2027, for all class III devices, and for class IIb implantable devices except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors; (b) 31 December 2028, for class IIb devices other than those covered by point (a) of this paragraph, for class IIa devices, and for class I devices placed on the market in sterile condition or having a measuring function.' The five-year certificate limit is verbatim from MDR Art. 56(2) (source res-eu-mdr-2017-745): 'The certificates shall be valid for the period they indicate, which shall not exceed five years.'

National registrations and notifications renew annually

validity.national-registrations-renew-annually
Fact-level verified

The Maltese national registrations do not lapse on a fixed term but renew annually against a fee: the distributor/importer organisation registration, the Medical Device Registered Person registration, and the device notification are each renewable annually. The annual invoice for organisation registration, MDRP and notified-body registrations is issued pro-rata to December of the year of approval and then annually for January to December; the device notification annual fee is invoiced for the product year, running from the month of approval. Annual fees are payable in full with no pro-rata adjustment on withdrawal, and the operator must notify the Authority before the year end to avoid being invoiced for the following year.

Conditions
  • Annual amounts (S.L. 458.46 Schedule 5): distributor/importer EUR 500; MDRP EUR 100; device notification EUR 15 per device group.
  • Withdrawal of a registration or of a product does not attract a fee but must be filed before the year end.
  • There is no time-limited Maltese device approval to renew; the substantive term belongs to the CE certificate.

Effective from 2025-01-01

Source language: English. Verbatim from Schedule 5: 'Initial Application for Organisation Registration of Distributor/Importer 500*', 'Annual Registration of Distributor / Importer (renewable annually) 500*', 'Annual Notification per device (renewable annually per group) 15*', 'Annual Registration of Medical Device Registered Person (MDRP) (renewable annually) 100*'. Annual-fee mechanics are further stated in the Authority's own guidance GL-MDF07/13 §3, which reproduces the same schedule: 'Once the initial application is approved by the Authority, a pro-rata annual fee invoice is issued by the Finance and Corporate Services Unit up to December of that year. Subsequently an invoice by the Authority is issued annually for the year January to December.'

Authority & regime

Which authority and binding regime govern this product, task, and date?

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Competent authority for medical devices: the Medicines Authority (Malta Medicines Authority)

authority.competent-authority-medicines-authority
Fact-level verified

The national competent authority for medical devices is the Medicines Authority established under article 4 of the Medicines Act (Cap. 458), designated by S.L. 458.59 as the authority in charge of regulating and ensuring compliance with the local and international laws applying to medical devices, and as the authority responsible for the designation and supervision of notified bodies concerned with medical devices in Malta. Its device work sits in the Medical Devices, Pharmaceutical Collaboration and Entrepreneurship Directorate, which processes national registrations and notifications, carries out market surveillance and post-market vigilance, designates and oversees notified bodies registered in Malta, and authorises clinical investigations and performance studies.

Conditions
  • The Authority brands itself 'Malta Medicines Authority'; the registry label 'Medicines Authority' matches the statutory name used in S.L. 458.59 reg. 2.
  • 'Competent authority' in S.L. 458.59 means the Medicines Authority, not a separate device agency.

Effective from 2020-08-04

Source language: English (the instrument is published in English and Maltese; the English text was read). Verbatim: 'The competent authority is designated under these regulations: (a) as the authority in charge of regulating and ensuring compliance and adherence to the applicable local and international laws that apply to medical devices; and (b) as the authority responsible for designation and supervision of notified bodies concerned with medical devices in Malta.' Regulation 2 defines 'competent authority' as 'the Medicines Authority as established under article 4 of the Medicines Act'. The directorate's functions are stated on the Authority's own Medical Devices page (res-mt-mma-medical-devices).

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

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Change control: amendment and withdrawal procedures with fast-track handling

change-control.national-amendment-and-withdrawal-procedures
Fact-level verified

Changes to a Maltese registration are filed as an amendment rather than a new application. The Authority maintains MT-MDF03, an application form for revision or withdrawal of a medical device registration, and MT-MDF02 and MT-MDF05 both carry an amendment/withdrawal track that requires the organisation registration number or the per-device MMA reference number to be quoted. Amendment fees are: EUR 100 to change organisation registration details (distributor/importer, manufacturer or authorised representative), EUR 100 to amend a device notification, EUR 50 to amend MDRP details. Withdrawal incurs no charge. The fee schedule marks these amendment applications as eligible for fast-track handling at double the fee.

Conditions
  • Withdrawal of a product or registration must be filed before the year end to avoid the following year's annual invoice (MMA GL-MDF07 §3).
  • For devices on the Directive-era transition, no significant change in design or intended purpose is permitted if the extended validity is to be relied on (MDR Art. 120(3c)(b)).
  • A change that affects conformity is a notified-body matter under the MDR before it is a national filing matter.

Effective from 2025-01-01

Source language: English. Verbatim from Schedule 5: 'Change in Organisation Registration Application details 100*', 'Amending Notification of Medical Device 100*', 'Amending Medical Device Registered Person (MDRP) details 50*', 'Amending Registration of Medical Device (Revised)' with 'Withdrawal incurs no charge'. The amendment forms are listed on the Authority's E-Forms for Medical Devices page and described in GL-MDF02 §4.3.1.2 and GL-MDF05 §4.3.

Classification rules

What local class follows from which rules and decisive product facts?

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Classification follows MDR Annex VIII, with a national risk-classification evaluation service

classification.annex-viii-rules-with-national-evaluation-service
Fact-level verified

Risk classification is governed by the classification rules of the Union Regulations; there is no Maltese classification schedule. An applicant, manufacturer or authorised representative with an official business address in Malta may nonetheless ask the Malta Medicines Authority to evaluate the risk classification of a device or an IVD, including in a dispute with the notified body over the application of Annex VIII (Classification Rules) of the MDR and IVDR. The fee for a request for confirmation of risk classification is EUR 1,000, on a 90-working-day processing timeframe.

Conditions
  • The national evaluation is advisory/confirmatory; the classification decision in a conformity assessment remains the notified body's.
  • The request may be made by an applicant, a manufacturer or an authorised representative with an official business address in Malta.

Effective from 2025-08-01

Source language: English. Verbatim §1: 'The applicant, manufacturer or authorised representative, who has an official business address in Malta may request the evaluation of the risk classification of a medical device or an in-vitro diagnostic, by the Malta Medicines Authority. The request may or may not arise from a dispute between the manufacturer and the notified body concerned, on the application of Annex VIII (Classification Rules) of the Medical Device Regulation and the In-Vitro Diagnostic Regulation.' The EUR 1,000 fee is from S.L. 458.46 Schedule 5 (source res-mt-sl-458-46): 'Request Form for Medical Device / In Vitro Diagnostic confirmation of risk classification 1,000'.

Clinical investigation & performance

Which clinical or IVD performance evidence or study is required and accepted?

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Clinical investigations and performance studies: national application, fees and adverse-event reporting

clinical-investigation.national-application-and-fees
Fact-level verified

Clinical investigations under the MDR and performance studies under the IVDR are authorised and overseen nationally by the Malta Medicines Authority. The Authority charges EUR 5,000 for an application/notification for a clinical investigation under Articles 62 and 74(1) of Regulation (EU) 2017/745 and EUR 5,000 for a performance study under Regulation (EU) 2017/746; EUR 1,000 for an application/notification under Article 82 of the MDR; EUR 1,000 for a pre-submission meeting request; and EUR 500 to modify a clinical investigation or performance study. The Authority also publishes GL-MDC01 on reporting adverse events in clinical investigations and performance studies, and runs initial inspections at EUR 1,500 and follow-up inspections at EUR 500.

Conditions
  • Application/notification forms are MT-MDF15 (MDR clinical investigation) and MT-MDF16 (IVDR performance study), with modification forms MT-MDF17 and MT-MDF18.
  • Application timeframes follow EU legislation and guidance-document timelines, not the 30-working-day national clock.

Effective from 2025-01-01

Source language: English. Verbatim rows: 'Application/notification for clinical investigation in accordance with Articles 62 and 74(1) of EU Regulation 2017/745 of the European Parliament and Council 5,000', 'Application/notification for clinical investigation in accordance with Article 82 of the EU Regulation 2017/745 ... 1,000', 'Application/notification for performance study in accordance with EU Regulation 2017/746 ... 5,000', 'Modification to Clinical Investigation/ Performance Study application 500', 'Clinical investigations/performance study initial inspection 1,500'. The Authority's oversight role and GL-MDC01 are published on its Medical Devices pages.

Device definition & scope

Is the product a device, IVD, accessory, software, or borderline product locally?

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Device definition and scope are taken directly from MDR Art. 2(1) and IVDR Art. 2(2)

scope.device-definition-is-derivative-of-mdr-and-ivdr
Fact-level verified

Maltese law does not define a medical device independently. S.L. 458.59 reg. 2 provides that 'medical device' means any medical device as defined in Article 2(1) of Regulation (EU) 2017/745 and any in-vitro diagnostic medical device as defined in Article 2(2) of Regulation (EU) 2017/746, and includes any product designated as such by the competent authority. The competent authority therefore retains a national power to designate a product as a device in addition to the Union definition. The regulations carry no separate device classification schedule, no national borderline-product list and no national scope annex.

Conditions
  • Because the definition is derivative, an MDR or IVDR scope amendment changes Maltese scope automatically.
  • The Authority publishes a Borderline Products activity page, so classification disputes are handled administratively.

Effective from 2020-08-04

Source language: English. Verbatim: ''medical device' means any medical device as defined in paragraph 1 of Article 2 of Regulation (EU) 2017/745, and any in-vitro diagnostic medical device as defined in paragraph 2 of Article 2 of Regulation (EU) 2017/746 and shall include any product designated as such by the competent authority;'.

Dossier requirements

Which evidence, local deltas, formats, and signatures are required?

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National device notification dossier: notification sheet, EU declaration of conformity, proof of payment

dossier.national-notification-requires-eu-declaration-of-conformity
Fact-level verified

The documents submitted with a Maltese medical device notification are the device notification sheet, the Declaration of Conformity (DoC) and proof of payment. The notification sheet must list each device being made available on the local market — including variants — with the source-country supplier, the product brand name, generic name, catalogue number, device type and class as written on the DoC, and, where applicable, the Basic UDI-DI and UDI-DI. The Authority may require any additional document relevant to the function of the organisation or the device. Every field must be completed, with 'N/A' where a section does not apply.

Conditions
  • The only conformity document the national filing consumes is the EU declaration of conformity; there is no slot for an FDA, PMDA, MFDS or NMPA clearance.
  • A regulatory affairs person (the MDRP or PRRC, as applicable) must sign a self-declaration that the notified devices comply with the applicable EU and national legislation.
  • Submitted by email to mdforms.medicinesauthority@gov.mt.

Effective from 2026-02-01

Source language: English. Verbatim: 'The documents to be submitted with this application form are: - Device notification sheet - Declaration of Conformity (DoC) - Proof of payment (softcopy)'. The field list is verbatim from Section D of the same guidance: 'MMA Reference Number, Product Brand Name, Generic Name, Catalogue Number, Device Type, Class and, where applicable, Basic UDI-DI and UDI-DI.'

Economic-operator roles

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

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Non-EU manufacturers must designate a sole EU authorised representative

operator.authorised-representative-for-non-eu-manufacturers
Fact-level verified

A manufacturer not established in a Member State may place a device on the Union market — and therefore on the Maltese market — only if it designates a sole authorised representative. The authorised representative must be established within the Union, accepts a written mandate that is effective at least for all devices of the same generic device group, and can be required to supply the mandate to the competent authority. Malta prices this role separately: an authorised representative established in Malta pays an initial organisation registration of EUR 500 and an annual organisation registration of EUR 1,000.

Conditions
  • IVDR equivalent: Article 11, Regulation (EU) 2017/746.
  • Post-Brexit, a UK manufacturer or a Maltese entity sourcing directly from the UK is treated as importing from a third country.
  • The AR organisation registration is renewed annually with a maximum of EUR 50,000 stated in the fee schedule.

Effective from 2021-05-26

Verbatim source passage. The Maltese fee amounts are from S.L. 458.46 Schedule 5 as added by Legal Notice 254 of 2025 (source res-mt-sl-458-46), heading 'Authorised Representative': 'Initial Application for Organisation Registration of Authorised Representative 500*', 'Annual Organisation Registration of Authorised Representative (maximum EUR 50,000) 1,000'.

Economic operator roles and the mandatory Medical Device Registered Person (MDRP)

operator.roles-and-medical-device-registered-person
Fact-level verified

S.L. 458.59 recognises four economic-operator roles — manufacturer, authorised representative, importer and distributor — and requires every operator that imports, wholesales, manufactures or re-purposes a device in Malta to have a medical device registered person in Malta. No one may act as a medical device registered person for a device locally without registering with the competent authority; registration yields a registration document. The Authority's guidance describes the MDRP as a person appointed by an economic operator, registered with the Malta Medicines Authority, responsible for ensuring regulatory compliance of devices placed on the Maltese market, and requires at least one such person in the organisation.

Conditions
  • The MDRP is a national overlay on the Union roles; the Union-side Person Responsible for Regulatory Compliance (PRRC) under MDR Art. 15 / IVDR Art. 15 is a separate appointment.
  • MDRP registration is an initial application plus an annual renewal (S.L. 458.46 Schedule 5, EUR 100 each).
  • Applies to manufacturers, authorised representatives, importers and distributors alike.

Effective from 2020-08-04

Source language: English. Verbatim reg. 6(1): 'No person shall act as a medical device registered person responsible for any medical device locally unless they have registered as such with the competent authority.' Regulation 5(2)(f) requires an applicant for importation, wholesaling, manufacturing or re-purposing to 'have a medical device registered person in Malta'. Regulation 2 defines 'economic operator' as 'a manufacturer, an authorised representative, an importer or a distributor of medical devices'.

Establishment, import & distribution

Which establishment licences, importer permissions, and distribution controls apply?

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Importation, wholesaling, manufacturing and re-purposing in Malta require authorisation

establishment.import-wholesale-manufacture-require-authorisation
Fact-level verified

No person may import, wholesale, manufacture or re-purpose in Malta any medical device intended for trade within the European Union or the local market before obtaining all the approvals, authorisations, licences, permits and notifications required by S.L. 458.59 or any other law. An applicant must comply with the regulations and with all national and Union requirements, obtain the necessary authorisation from the competent authority, hold the qualifications and training the Authority requires, have a medical device registered person in Malta, and insert the details of every device it markets locally into the national medical device database kept by the Authority.

Conditions
  • A Maltese entity sourcing devices directly from a third country (including the United Kingdom after Brexit) is an importer and must register as such with the Authority.
  • Importers and distributors must operate under Good Distribution Practice conditions and maintain a quality management system (MMA GL-MDS01).
  • Storage sites do not need a Wholesale Dealer's Licence for medical devices (MMA Factsheet for Importers & Distributors).

Effective from 2020-08-04

Source language: English. Verbatim reg. 5(1): 'No person shall carry out importation, wholesaling, manufacturing or re-purposing in Malta of any medical device which is intended for trade within the European Union and, or the local market prior to obtaining all the necessary approvals, authorisations, licences, permits and, or any notification/s as required by or under these regulations or any other law.' Regulation 5(2) then lists sub-paragraphs (a) to (g), including '(f) have a medical device registered person in Malta; and (g) insert details of all medical devices which he markets locally in the national medical device database kept by the competent authority.'

Fees

What regulator fee applies to this class, route, event, and date?

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Fees: S.L. 458.46 Schedule 5, as added by Legal Notice 254 of 2025

fees.schedule-5-medical-device-fees
Fact-level verified

Medical-device fees are set in Schedule 5 of the Medicines Authority (Fees) Regulations S.L. 458.46, added by Legal Notice 254 of 2025. Key amounts in euro: distributor/importer organisation registration EUR 500 initial and EUR 500 annual; manufacturer based in Malta EUR 2,500 initial registration with an annual fee banded by headcount from EUR 250 (under 5 employees) to EUR 25,000 (over 150); non-EU manufacturer whose authorised representative is based in Malta EUR 2,500 initial and EUR 2,500 annual; authorised representative organisation registration EUR 500 initial and EUR 1,000 annual; initial notification of a device per manufacturer EUR 100 with EUR 15 annual per group; MDRP registration EUR 100 initial and EUR 100 annual; change of organisation details EUR 100; amending a device notification EUR 100; certificate of free sale EUR 250 per declaration of conformity; device registration for the European market EUR 100 per declaration of conformity; derogation applications EUR 1,000 (renewal EUR 750); non-CE marked device for use in Malta EUR 500; scientific advice EUR 2,300; search of the national medical devices database EUR 50. All Schedule 5 fees are non-refundable.

Conditions
  • Applications marked with an asterisk in the schedule are eligible for fast-track service at double the original fee.
  • Fees are payable to the Medicines Authority's HSBC Malta account; proof of payment must accompany the application.
  • Notified-body designation fees are also in Schedule 5: EUR 30,000 initial setup, EUR 10,000 extension of scope, EUR 20,000 annual.

Effective from 2025-01-01

Source language: English. Verbatim rows quoted: 'Initial Application for Organisation Registration of Distributor/Importer 500*', 'Initial Application for Organisation Registration application of Manufacturer 2,500*', 'Initial Application fee for Manufacturer (Non-EU) with Authorised Representative is based in Malta 2,500*', 'Initial Application for Notification of device per manufacturer 100', 'Annual Notification per device (renewable annually per group) 15*', 'Certificate of Free Sale application (per DoC) 250*', 'Derogation application in terms of Article 59 of Regulation (EU) 2017/745 ... and Article 54 of Regulation (EU) 2017/746 ... 1,000', 'Application for use of a Non-CE marked medical device in Malta 500', 'Scientific Advice request 2,300', 'Search Function fee of national medical devices database 50'. The schedule states 'All fees under Schedule 5 are non-refundable.' The same schedule is reproduced by the Authority in GL-MDF07/13, which records that the fees are 'laid out in Subsidiary Legislation S.L.458.46, as amended by Legal Notice 254 of 2025 under schedule 5'.

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

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Labelling and instructions for use: English, Maltese, or both

label.language-english-maltese-or-both
Fact-level verified

Medical devices and all accompanying information placed on the Maltese market must be in one of the national languages of Malta — English and Maltese, or both. The Authority states the requirement twice: that devices and all accompanying information must be in one of the national languages of Malta, English and Maltese or both, and that labelling of medical devices must be in English or Maltese to be placed on the Maltese market. Because English is an official language of Malta, an English-only label satisfies the national language duty.

Conditions
  • Union rule behind it: MDR Art. 10(11) requires the information in Section 23 of Annex I to be in an official Union language determined by the Member State in which the device is made available.
  • All national application forms and supporting documentation must likewise be completed in Maltese or English (MMA GL-MDF02 §4.2.4).

Effective from 2021-05-26

Source language: English. Verbatim, page 1: 'Medical devices and all accompanying information must be in one of the national languages of Malta; English and Maltese, or both.' Verbatim, page 6: 'Labelling of medical devices must be in English or Maltese to be placed on the Maltese market.' The Union-side obligation is MDR Art. 10(11), for which the Union does not itself fix the language.

Relabelling or repackaging: 28 days' notice to the manufacturer and the Authority

label.relabelling-or-repackaging-28-day-notice
Fact-level verified

Any relabelling or repackaging of a medical device within the meaning of Article 16(2) of the MDR must be communicated to the manufacturer and to the Malta Medicines Authority at least 28 days before the relabelled or repackaged device is made available on the market. Within the same 28 days the distributor or importer must submit to the Authority a certificate issued by a notified body designated for that type of device, demonstrating that its quality management system complies with the Article 16(2) requirements. On request, a sample or mock-up of the relabelled or repackaged device, including any translated label and instructions for use, must be made available to the manufacturer and to the Authority.

Conditions
  • Applies to distributors and importers who carry out relabelling or repackaging under MDR Art. 16(3)-(4) conditions; it is not a general labelling change notification.
  • The 28-day period runs before placing the relabelled device on the market, not before the change is made.

Effective from 2021-05-26

Source language: English. Verbatim: 'Labelling of medical devices must be in English or Maltese to be placed on the Maltese market. Any relabelling or repackaging of a medical device, as stated in article 16(2) of the MDR, must be communicated with the manufacturer and the Malta Medicines Authority at least 28 days prior to making the relabelled or repackaged device available on the market.'

Manufacturer PMS

Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?

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Manufacturer post-market surveillance: Union system, with a Maltese complaints register on operators

pms.manufacturer-post-market-surveillance-system
Fact-level verified

For each device, the manufacturer must plan, establish, document, implement, maintain and update a post-market surveillance system proportionate to the risk class and appropriate to the device type, as an integral part of the quality management system required by MDR Article 10(9). The system must actively and systematically gather, record and analyse data on quality, performance and safety throughout the device's lifetime and determine, implement and monitor preventive and corrective actions. On the Maltese side, every economic operator must keep a register of complaints, of non-conforming devices and of recalls and withdrawals and keep the competent authority informed of that monitoring; the Authority's directorate states that it oversees post-market activities and addresses incident reports.

Conditions
  • Periodic reporting escalates with class: a PMCF plan and report, a post-market surveillance report for class I, and a periodic safety update report for higher classes under MDR Arts. 84-86.
  • IVDR equivalent: Articles 78-81, Regulation (EU) 2017/746.
  • The Maltese operator register is an overlay, not a substitute for the manufacturer's Union-side surveillance system.

Effective from 2021-05-26

Verbatim source passage. The Maltese operator-side register duty is S.L. 458.59 reg. 10(2) and is recorded as a separate fact in this file; the Authority's post-market oversight role is stated on res-mt-mma-medical-devices.

Official forms & portals

Which current form, portal, account, and submission package must be used?

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Official forms MT-MDF02/03/05/11/12/13 and the email submission channel

forms.application-forms-and-email-submission-channel
Fact-level verified

Maltese medical-device applications are made on the Authority's own numbered forms: MT-MDF02 organisation registration, MT-MDF03 revision or withdrawal of a device registration, MT-MDF04 use of a non-CE marked device on a named-patient basis, MT-MDF05 notification of devices made available on the local market, MT-MDF11 application for a Medical Device Registered Person, and MT-MDF12/MT-MDF13 derogation applications. The forms are fillable and must be completed electronically — handwritten forms are not accepted — and a signed scanned copy of the completed form with supporting documentation is submitted by email to mdforms.medicinesauthority@gov.mt. A declaration form is attached to each e-form.

Conditions
  • Section-not-applicable fields must be filled with 'N/A'; incomplete applications are not considered.
  • Proof of payment must accompany the submission.
  • The Authority also publishes the corresponding guidance documents GL-MDF01 to GL-MDF21, GL-MDC01 and GL-MDS01.

Effective from 2026-02-01

Source language: English. Verbatim §4.2.2: 'The registration is a fillable form which must be filled in electronically using the grey-shaded areas. Handwritten application forms will not be accepted. A signed scanned copy of the completed form and supporting documentation must be submitted to the Malta Medicines Authority via email on mdforms.medicinesauthority@gov.mt.' The form inventory is as published on the Authority's E-Forms for Medical Devices page; MT-MDF12 and MT-MDF13 are named in GL-MDF19 §1.

QMS, audit & inspection

Which QMS, audit, inspection, and certificate scope is accepted or required?

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Inspection powers and the Good Distribution Practice conditions on operators

inspection.premises-inspection-powers-and-gdp-conditions
Fact-level verified

The competent authority monitors and reviews operations conducted within premises to ensure the regulations are complied with, and for that purpose it — or any person authorised by it — has the right at all reasonable times, and where necessary with the assistance of the Executive Police, to enter and inspect any premises. Operators making devices available on the Maltese market must be registered with the Malta Medicines Authority, must have at least one registered Medical Device Registered Person with the requisite knowledge and experience in distribution and post-marketing activities, and must operate under Good Distribution Practice conditions with an effective quality management system covering documentation, personnel training, complaints handling, returns and recall procedures.

Conditions
  • Storage sites do not need a Wholesale Dealer's Licence for medical devices, but GDP conditions apply (MMA Factsheet for Importers & Distributors).
  • Inspection fees (S.L. 458.46 Schedule 5): EUR 1,500 per day per surveillance-team member and EUR 200 per hour per member; inspection letters for manufacturer, authorised representative and distributor/importer every three years at EUR 500/500/300.

Effective from 2020-08-04

Source language: English. Verbatim reg. 9(2): 'For the purposes of this regulation, the competent authority or any person so authorised shall have the right at all reasonable times and, where necessary, with the assistance of the Executive Police to enter and inspect any premises.' The GDP/MDRP conditions are verbatim from GL-MDS01/04 §3 (source res-mt-mma-gl-mds01): 'Economic operators making medical devices available on the Maltese market shall be registered with the Malta Medicines Authority (MMA). These operators shall have available in their organisation at least one person responsible for regulatory compliance; a Medical Device Registered Person (MDRP), who is registered with the MMA and possesses the requisite knowledge and experience in the distribution and post-marketing activities concerning medical devices.'

Recall, FSCA & market surveillance

Which recall, FSCA, notice, and authority-coordination duties apply?

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Recall and field safety: operator register, FSCA reporting and the Authority's FSN repository

recall.register-of-recalls-and-field-safety-notices
Fact-level verified

Every economic operator must keep a register containing details of complaints, of non-conforming devices and of recalls and withdrawals, and must keep the competent authority informed of that monitoring. On the Union side, manufacturers must report any field safety corrective action in respect of devices made available on the Union market, including a corrective action taken in a third country on a device also lawfully made available in the Union where the reason for it is not limited to the third-country device. The Malta Medicines Authority maintains a repository of medical device field safety notices for devices available in Malta, monitors their dissemination, tracks implementation of corrective actions and reports on them.

Conditions
  • Non-conforming device under S.L. 458.59 reg. 2 means any device that does not fulfil its specified requirements under the regulations or any other law.
  • The Authority has right of entry to inspect premises at all reasonable times, with the assistance of the Executive Police where necessary (S.L. 458.59 reg. 9(2)).

Effective from 2020-08-04

Source language: English. Verbatim: 'Every economic operator shall keep a register containing details of complaints, of non-conforming medical devices and of recalls and withdrawals of medical devices, and shall keep the competent authority informed of such monitoring.' The Union-side FSCA duty is MDR Art. 87(1)(b) (source res-eu-mdr-2017-745). The Authority's FSN repository and tracking activity are stated on its Medical Device Field Safety Notices page at medicinesauthority.gov.mt/mdfsn.

Registration pathways

Which registration, notification, listing, reliance, or conformity route applies?

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Registration pathway: CE conformity plus national organisation registration and device notification

registration-pathways.ce-route-plus-national-operator-and-device-registration
Fact-level verified

There is no Maltese pre-market approval of a medical device. The pathway has two national steps on top of the CE conformity route: (1) organisation registration of the economic operator with the Malta Medicines Authority (form MT-MDF02), and (2) notification of each device made available on the local market (form MT-MDF05), with a Medical Device Registered Person registered separately (form MT-MDF11). A device notification is submitted by economic operators with a registered place of business in Malta, or by operators with a place of business outside Malta that have no local supplier in Malta. The Authority describes organisation registration as existing to increase visibility and traceability and to enable communication between the operators and the Authority.

Conditions
  • Operators already registered with the Authority must be registered before they can submit a device notification.
  • Both steps are fee-bearing and both renew annually (S.L. 458.46 Schedule 5).
  • The device notification is a transparency/traceability filing; the substantive conformity decision remains with the notified body under the MDR/IVDR.

Effective from 2026-02-01

Source language: English. Verbatim: 'The application form for notification of medical devices made available on the local market, may be submitted by economic operators with a registered place of business in Malta and economic operators with a registered place of business out of Malta but with no local supplier in Malta. Economic operators with a registered place of business in Malta submitting the application must be registered with the Malta Medicines Authority.' The organisation-registration half is at res-mt-mma-gl-mdf02 §4.1: 'The application form for an organisation registration may be requested by a manufacturer, authorised representative, importer, distributor and a notified body in relation to medical devices.'

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

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Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Malta approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Malta (4 records)

MaltaUS FDA · Japan MHLW / PMDA · South Korea MFDS · NMPA

Prior approval / evidence record

No route for a third-country approval (FDA, PMDA, MFDS, NMPA)

reliance.no-third-country-approval-route
Fact-level verified
Statement

Malta gives no market-access route, abridged review or recognition to a US FDA 510(k)/PMA clearance, a Japan PMDA approval, a Korea MFDS approval or a China NMPA registration. The only pre-market route onto the Maltese market is the EU conformity assessment under Regulation (EU) 2017/745 (MDR) Annexes IX to XI — Regulation (EU) 2017/746 (IVDR) for IVDs — followed by CE marking; S.L. 458.59 defines a 'medical device' solely by reference to those two Union Regulations, so the national regime has no approval of its own that a third-country clearance could feed. A holder of only a third-country approval must obtain a CE certificate (or use the MDR Art. 59 / IVDR Art. 54 public-health derogation) and appoint an EU authorised representative.

Source Approval

none

Edge Type

No Reliance Route

Market Access Strength

none

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Applies to medical devices under the MDR and IVDs under the IVDR placed on the Maltese market.
  • A manufacturer not established in a Member State may place a device on the Union market only if it designates a sole authorised representative (MDR Art. 11(1); IVDR Art. 11(1)).
  • The national definition of a device is derivative: S.L. 458.59 reg. 2 refers to MDR Art. 2(1) and IVDR Art. 2(2).
  • The only non-CE entry route is a derogation under MDR Art. 59 / Art. 97 or IVDR Art. 54 / Art. 92 (S.L. 458.46 Schedule 5, fee EUR 1,000), which is granted on public-health or patient-safety grounds and is not a recognition of a foreign approval.

Effective from 2021-05-26

Verbatim passage supports the mandatory-and-exclusive character of the EU conformity route. Regulation (EU) 2017/746 Art. 48(1) is identically worded for IVDs (source res-eu-ivdr-2017-746): 'Prior to placing a device on the market, manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures set out in Annexes IX to XI.' Neither Regulation contains any provision recognising, or providing an abridged route on the basis of, a third-country marketing authorisation of the kind issued by FDA, PMDA, MFDS or NMPA; that absence is the basis of this fact rather than a quotable clause.

MaltaNMPA

Prior approval / evidence record

China NMPA approval: no recognition regime

reliance.china-nmpa-no-recognition-route
Fact-level verified
Statement

A China NMPA registration certificate or Class I filing gives no market-access route in Malta. Regulation (EU) 2017/745 Art. 52(1) (and Regulation (EU) 2017/746 Art. 48(1) for IVDs) requires the manufacturer to complete the EU conformity assessment in Annexes IX to XI before placing the device on the market; the Regulation contains no reliance or abridged procedure based on a third-country marketing authorisation, so the NMPA certificate is not assessed and the Chinese manufacturer needs a CE conformity route plus an EU authorised representative.

Source Jurisdiction Id

china

Source Authority Id

nmpa

Source Approval

China NMPA medical device registration certificate (Class II/III) or Class I filing record

Target Jurisdiction Id

malta

China Classes In Scope

All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes

Edge Type

No Reliance Route

Market Access Strength

none

Regulatory Layer

Product Marketing

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Recorded with the same key as the other EU/EEA markets in the round-203 China NMPA set so Malta is not a hole in that comparison.
  • A non-EU manufacturer must designate an EU authorised representative (MDR Art. 11 / IVDR Art. 11).
  • Chinese test reports or NMPA review files may be reused as technical-documentation evidence only insofar as the notified body accepts them; they do not replace conformity assessment.

Effective from 2021-05-26

Verbatim source passage. The Maltese national instrument adds nothing: S.L. 458.59 reg. 2 defines 'medical device' by reference to MDR Art. 2(1) and IVDR Art. 2(2) only, so the national regime recognises no third-country approval category.

MaltaUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority

FDA 510(k)/PMA

Accepted

No

Benefit

No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

EUR-Lex Regulation (EU) 2017/745 (MDR)MDR Annex IX — conformity assessment based on a quality management system and on assessment of technical documentation (§5.1 expert-panel consultations, §5.2(d) medicinal-products authority opinion)Commission Implementing Regulation (EU) 2026/977, Art. 2 — maximum notified-body conformity assessment timelines (30 + 120/90 parallel + 20 days)Medicines Authority (Fees) Regulations, S.L. 458.46, Schedule 5 (added by L.N. 254 of 2025) — the 30-working-day standard service, the 10-working-day fast-track and the 90-working-day notesMedical Devices and In-Vitro Diagnostic Medical Devices Provision on the Maltese Market Regulations, S.L. 458.59 (L.N. 321 of 2020) — competent authority, registered person and national medical device database

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

MaltaEU conformity assessment

Prior approval / evidence record

EU/EEA CE marking under MDR/IVDR — the domestic route, free movement into Malta

reliance.eu-ce-marking-single-market-route
Fact-level verified
Statement

CE marking under Regulation (EU) 2017/745 (MDR) or Regulation (EU) 2017/746 (IVDR) is not a foreign approval in Malta — it is the domestic route. A device that complies with the applicable Union Regulation may be placed on the Maltese market without any Maltese pre-market review of the device, because Member States may not refuse, prohibit or restrict the making available of a compliant device on their territory. The device does not need to be re-certified, re-registered or re-approved in Malta. Local obligations still attach to the entities and to the presentation of the device: the Maltese economic operator must register with the Malta Medicines Authority, appoint a registered Medical Device Registered Person, enter the devices in the national medical device database, and label in English or Maltese.

Source Approval

EU CE Marking under MDR (Regulation (EU) 2017/745) / IVDR (Regulation (EU) 2017/746)

Edge Type

Single Market Validity

Market Access Strength

direct

Regulatory Layer

Product Marketing

Local Application Required

No

Target Decision Retained

No

Conditions
  • This is the domestic conformity route, not a recognition of another jurisdiction's approval; a CE certificate issued by a notified body anywhere in the Union or EEA is valid for Malta.
  • Operator-side duties remain: organisation registration, MDRP registration, device notification and the national database entry (S.L. 458.59 regs. 5(2)(f)-(g) and 6; MMA GL-MDF02 and GL-MDF05).
  • Information supplied with the device must be in English, Maltese or both (MMA Factsheet for Importers & Distributors).
  • IVDR equivalent of the free-movement clause: Article 21, Regulation (EU) 2017/746.
  • Where the device relies on a Directive-era certificate, Regulation (EU) 2023/607 extended validity to 31 December 2027 (class III and class IIb implantable) or 31 December 2028 (other class IIb, class IIa, and class I sterile or with a measuring function).

Effective from 2021-05-26

The quoted free-movement clause is the Union rule that makes a CE-marked device directly placeable in Malta; the operator-side conditions listed here come from the Maltese instrument and the Authority's own guidance, and are recorded as separate facts.

Review clocks

What review, validation, and applicant stop-clock rules apply?

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Derogation applications (MDR Art. 59/97, IVDR Art. 54/92) run on a 90-working-day clock; extensions must be re-applied for three months before expiry

clock.derogation-90-working-days-and-three-month-extension-lead
Fact-level verified

Upon submission of all relevant documentation, a standard processing timeframe of 90 working days commences for an application on forms MT-MDF12 and MT-MDF13 for a derogation from the conformity assessment procedures. Where an extension of the derogation is required, the applicant must re-apply three months before the end of the approved derogation period. A stop-clock applies while the Authority awaits further information, repeating for further queries.

Conditions
  • Guidance-level restatement of the 90-working-day derogation timeline in S.L. 458.46 Schedule 5, adding the three-month re-application lead time and the stop-clock rule.
  • Fees are those in GL-MDF07 / S.L. 458.46 (EUR 1,000 initial, EUR 750 renewal).

Effective from 2026-02-01

English source.

A device notification is automatically refused if the applicant gives no feedback within 90 working days of the Authority's last communication

clock.notification-auto-refusal-after-90-working-days-without-feedback
Fact-level verified

If, during application review, the Authority does not receive feedback from the applicant within 90 working days from the Authority's last communication, the application is automatically refused; the applicant is responsible for providing all required feedback and documentation within the specified timeframes.

Conditions
  • Applicant-side clock attached to the MT-MDF05 notification procedure; refusal is automatic and payments are not refunded.

Effective from 2026-02-01

English source.

Risk-classification evaluation requests (MT-MDF21) run on a 45-working-day clock with no fast track

clock.risk-classification-evaluation-45-working-days
Fact-level verified

A request by a Malta-established applicant, manufacturer or authorised representative for the Authority's evaluation of the risk classification of a device or IVD, whether or not it arises from a dispute with a notified body over Annex VIII, is processed within 45 working days from submission of all documentation and fees. The fast-track option does not apply; a stop-clock runs while further information is awaited, repeating for further queries.

Conditions
  • The fee schedule in S.L. 458.46 Schedule 5 states a 90-working-day timeline for the 'confirmation of risk classification' request; the August 2025 guidance gives 45 working days for the same evaluation service, so the two official statements conflict and the guidance is the more recent.
  • Available only to applicants with an official business address in Malta.

Effective from 2025-08-01

English source. The conflict with Schedule 5 of S.L. 458.46 ('Request Form for Medical Device / In Vitro Diagnostic confirmation of risk classification ... Timeline for the processing of an application is within a 90 working day timeframe') is recorded in the conditions rather than resolved.

Review clocks: 30 working days standard, 10 working days fast track, 90 for derogations

review-clocks.30-working-day-standard-10-working-day-fast-track
Fact-level verified

The standard service for processing an application under S.L. 458.46 Schedule 5 is 30 working days from submission of the application and supporting documentation. Fast-track service is available for the applications marked with an asterisk in the schedule and completes within 10 working days, at double the fee. Where the Authority requires further information or clarification it communicates this to the applicant, the clock is interrupted and it recommences on receipt of the response — the Authority's own guidance describes the same stop-clock restarting as further queries arise. Derogation applications and requests for advice on making available a device in Malta are on a 90-working-day timeframe, and clinical investigation and performance study applications follow Union legislation and guidance timelines rather than a national clock.

Conditions
  • These are national administrative clocks for the registration, notification and derogation steps; they do not describe notified-body conformity-assessment time.
  • The clock is stopped whenever the Authority raises a query.
  • Withdrawal at any stage does not attract a refund or credit.

Effective from 2025-01-01

Source language: English. Verbatim: 'Standard service for the processing of an application is within a 30 working day timeframe from date of submission of the application and supporting documentation, unless otherwise specified with respective application fee details, below. Fast-track service is available for selected applications (marked with an asterisk*), for the processing of the application to be completed within a 10 working day timeframe. If the Authority requires any further information and, or clarification, this shall be communicated to the applicant and the time period shall be interrupted and the time period shall recommence to run, accordingly, upon receipt of the applicant's response.' The derogation note reads 'Timeline for the processing of an application is within a 90 working day timeframe from date of submission of the application and supporting documentation.'

Special access & derogation

Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?

Compare countries

National derogation from conformity assessment and related non-CE-device services

special-access.derogation-from-conformity-assessment
Fact-level verified

By way of derogation from Article 52, the competent authority may authorise, on a duly justified request, the placing on the market or putting into service within Malta of a specific device for which the conformity assessment procedures have not been carried out, where its use is in the interest of public health or patient safety or health. The Authority charges EUR 1,000 for a derogation application and EUR 750 for its renewal, both under the Derogations group's 90-working-day processing note, and EUR 500 for an application for use of a non-CE marked device in Malta, which carries no special note and so falls under the 30-working-day standard service.

Conditions
  • A derogation granted for use other than for a single patient must be notified by Malta to the Commission and the other Member States.
  • The Commission may in exceptional cases extend a national authorisation to the Union territory by implementing act.
  • The Authority also runs a separate named-patient route for non-CE marked devices (form MT-MDF04).

Effective from 2025-01-01

MDR consolidated text, 19 July 2026

Source language: English. Verbatim from Schedule 5: 'Derogation application in terms of Article 59 of Regulation (EU) 2017/745 of the European Parliament and Council and Article 54 of Regulation (EU) 2017/746 ... 1,000', the Art. 97 / Art. 92 line at 1,000, the renewal line at 750, and 'Application for use of a Non-CE marked medical device in Malta 500'. The mechanism is stated verbatim by the Authority in GL-MDF19/02 §1 (source res-mt-mma-gl-mdf19): 'MDR Article 59 and Article 97 and IVDR Article 54 and Article 92 enable the national competent authority to grant local or Union wide market access for medical devices while the devices are not yet fully compliant with the relevant EU Regulations especially in cases where a scarcity of suitable alternatives is present within the market.' The Art. 59(1) text is quoted from MDR (source res-eu-mdr-2017-745).

Standards, testing & ancillary approvals

Which standards, tests, and radio, electrical, metrology, or other overlays are triggered?

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Harmonised standards presumption applies directly, with no separate national standards list

standards.harmonised-standards-presumption-of-conformity
Fact-level verified

Because the MDR and IVDR apply directly in Malta and S.L. 458.59 has no standards annex or national standardisation schedule, the conformity presumption is the Union one: devices in conformity with the relevant harmonised standards, or the relevant parts of them, whose references have been published in the Official Journal of the European Union, are presumed to conform to the requirements of the Regulation covered by those standards. The same presumption applies to system or process requirements imposed on economic operators or sponsors, including those relating to quality management systems, risk management, post-market surveillance, clinical investigations, clinical evaluation and post-market clinical follow-up.

Conditions
  • The presumption operates only for standards whose references the Commission has published in the Official Journal; no Maltese list is maintained.
  • IVDR equivalent: Article 7, Regulation (EU) 2017/746.

Effective from 2021-05-26

Verbatim source passage. The absence of a national standards annex was checked by reading S.L. 458.59 in full (11 regulations, no standards provision).

Submission communications & appeal

How are deficiencies answered, clocks handled, and decisions escalated or appealed?

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Submission channel and appeal route for device decisions in Malta

submission.notification-e-forms-and-judicial-review-under-cap-12-469a
Fact-level verified

Submissions to the Maltese competent authority are made on the Medicines Authority's medical-device e-forms: MT-MDF02 for organisation registration, MT-MDF05 for notification of medical devices made available on the local market, MT-MDF03 for revision or withdrawal of a device registration, with incident reports filed on the health-care-professional and public incident report forms, and the Directorate reachable for guidance at devices.medicinesauthority@gov.mt. The Authority has separately noticed economic operators to register their organisation and to notify the devices they make available, both stated to be in line with S.L. 458.59. There is no appeal provision in the device regulations: S.L. 458.59 contains no reference to an appeal, a tribunal or a review of a decision, so a decision of the Authority is contested by the ordinary Maltese judicial-review action. Under Article 469A of the Code of Organization and Civil Procedure (Cap. 12) the civil courts may enquire into the validity of an administrative act and declare it null, invalid or without effect where it violates the Constitution or is ultra vires on one of four grounds; the action must be filed within six months from the date the interested person became aware or could have become aware of the act, and the article does not apply where another law provides the mode of contestation. The Administrative Review Tribunal under the Administrative Justice Act (Cap. 490) is not that route: by Article 5(2) it has no general jurisdiction over administrative acts reviewable under Article 469A of Cap. 12 and reviews only classes of acts prescribed for it by or under the Act or another law.

Conditions
  • Filing is by e-form to the Medicines Authority; the device regulations impose the notification duty on the economic operator and the Authority supplies a form for each step rather than a single submission procedure.
  • No appeal lies within the device regime: S.L. 458.59 provides no appeal, tribunal or review of a decision, and no other Maltese law was found conferring jurisdiction on the Administrative Review Tribunal over device decisions.
  • The judicial-review action under Article 469A(1)(b) of Cap. 12 must be filed within six months from the date the interested person became aware or could have become aware of the administrative act, whichever is earlier; the grounds are violation of the Constitution or ultra vires in one of the four senses listed in the article.
  • Article 469A(4) makes the article residual: it does not apply where the mode of contestation of, or of obtaining redress against, the particular administrative act before a court or tribunal is provided for in any other law.
  • Under Article 469A(2) the absence of a decision following a written demand constitutes a refusal after two months, except where the law prescribes a period for the decision.
Medicines Authority — Medical Devices Forms (E-Forms for Medical Devices: MT-MDF02 organisation registration, MT-MDF03 revision or withdrawal, MT-MDF05 notification of devices made available on the local market, and the incident-report forms)Medicines Authority Notifications — Ref. MA/MDPCD-001/2023 (organisation registration) and Ref. MA-MDPCD-002-2023 (product notification) of 21 July and 11 September 2023Administrative Justice Act (Cap. 490) — Article 5 (establishment and jurisdiction of the Administrative Review Tribunal) and Article 7 (review of administrative acts; six-month time limit)Medical Devices and In-Vitro Diagnostic Medical Devices Provision on the Maltese Market Regulations (S.L. 458.59), Legal Notice 321 of 2020

Both limbs come from official Maltese sources read on 2026-09-16. Submission limb, verbatim from the Medicines Authority's Medical Devices Forms page: "E-Forms for Medical Devices — The listed e-forms are tailored for Economic Operators, healthcare professionals, and other stakeholders involved in the medical device lifecycle. Whether you are registering a new device, submitting incident reports, or updating existing information, these user-friendly forms ensure efficiency and accuracy."; "For further assistance or guidance on using these e-forms, please contact the Medical Devices, Pharmaceutical Collaboration and Entrepreneurship Directorate at devices.medicinesauthority@gov.mt ."; and the forms themselves: "MT-MDF02 Application for Organisation Registration in relation to Medical Devices", "MT-MDF03 Application Form for Revision or Withdrawal of Medical Device Registration", "MT-MDF04 Request Form for the Use of a Non-CE Marked", "MT-MDF05 Application Form for Notification of Medical Devices Made Available on the Local Market", "MT-MDF14 Application for pre-submission meeting request for clinical investgations or performance studies", "MT-MDF15 Clinical Investigation – Application or Notification form under the Medical Device Regulation", "MT-MDF16 Performance Study– Application or Notification form under the In Vitro Diagnostic Regulation", "MT-MDF17 Notification for Modification of Clinical Investigation under the MDR", "MT-MDF18 Notification for Modification of Performance Study under the IVDR", "MT-MDF19 Request form for Medical Device-IVD advice", "MT-MDF20 Application Form for Medical Device / In-Vitro Diagnostic Evaluation of Risk Classification", "MT-MDF23 Application Form for Device Registration to place devices on the EU Market - Manufacturers / Authorised Representatives", followed by "Incident Report Forms — Health Care Professional Incident Report Form", "Public Incident Report Form". The Authority's notices page carries the two operative notices, verbatim: "11/09/2023 Ref: MA-MDPCD-002-2023 Notice to Stakeholders – Product Notification relevant to Medical Device Regulatory Sciences in Malta. The Malta Medicines Authority issues a notice to economic operators in Malta to notify the Authority with medical devices being makde availble on the Maltese market, in line with Subsidiary Legislation 458.59 Medical Devices and In Vitro Diagnostic Medical Devices Provision on the Maltese Market Regulation. Application and Guidelines are available on < here >. Notice can be downloaded below." and "21/07/2023 Ref: MA/MDPCD-001/2023: Notice to Stakeholders – Organisation Registration relevant to Medical Device Regulatory Sciences in Malta. The Malta Medicines Authority issues a notice to economic operators in Malta to register their organisation with the Authority, in line with Subsidiary Legislation 458.59 …" (the typographical errors "makde availble" and the trailing full stop after "Regulation ." are in the original). Appeal limb: S.L. 458.59 was read in full and contains zero occurrences of "appeal" and zero of "Tribunal", so no appeal within the device regime is asserted. The Administrative Justice Act (Cap. 490) was read to test the alternative and its Article 5 states, verbatim: "5. (1) There shall be set up in accordance with the provisions of this Part of this Act, an independent and impartial tribunal, to be known as the Administrative Review Tribunal, for the purpose of reviewing administrative acts referred to it in accordance with this Act or any other law, and for the purpose of exercising any other jurisdiction conferred on the Administrative Review Tribunal by or under this or any other law, whether before or after the coming into force of this Act. (2) The Administrative Review Tribunal shall not have a general jurisdiction to review administrative acts which are reviewable under article 469A of the Code of Organization and Civil Procedure but it shall have jurisdiction to review those administrative acts as may be prescribed in or under this Act or any other law granting jurisdiction to the Administrative Review Tribunal over any class of administrative acts." and Article 7: "(1) The Administrative Review Tribunal shall be competent to review administrative acts of the public administration on points of law and points of fact. (2) Subject to the provisions of article 5 and where a special law confers jurisdiction to the Administrative Review Tribunal and unless any provision of the law does not provide for any time limit for the filing of an action for review by the Administrative Review Tribunal, an action to review administrative acts of the public administration under this Act shall be filed within a period of six months from the date when the interested person becomes aware or could have become aware of such an administrative act, whichever is the earlier." No Maltese law conferring jurisdiction on the Tribunal over decisions of the Medicines Authority on devices was found, which is why Article 469A of Cap. 12 and not the Tribunal is recorded; the six-month period is the same under both routes, so nothing turns on the distinction for timing. The Medicines Act (Cap. 458) does provide appeals — the Medicines Review Board, whose procedure article 17 describes as available to "an applicant for a marketing authorisation" — but that route is drafted for marketing authorisations of medicinal products and is not asserted here as a route against device decisions. Provenance of the Maltese texts quoted in this fact: each was read on 2026-09-16 in the PDF served by legislation.mt for the instrument cited — the site's viewer endpoint /getpdf/<id>, linked from the /eli/... landing page recorded as the source URL — extracted with pdftotext -layout; S.L. 458.59 was read in full in that form (120,393 bytes, eleven regulations), Cap. 12 was read at Article 469A (2,469,537 bytes) and Cap. 490 at Articles 5 to 7 (312,631 bytes).

UDI, listing & traceability

Which UDI, device listing, database, and traceability duties apply?

Compare countries

UDI data is carried into the national device notification; EUDAMED registration is the Union layer

udi.basic-udi-di-and-udi-di-in-national-device-notification
Fact-level verified

Where applicable, the Basic UDI-DI and the UDI-DI of a device, as written on its EU declaration of conformity, must be entered on the Maltese device notification sheet, along with the MMA reference number, product brand name, generic name, catalogue number, device type and class. Operators also supply their Single Registration Number (SRN) generated by EUDAMED, where applicable, on both the organisation registration and the device notification. Importers and distributors sourcing from third countries must register as actors in EUDAMED as well as registering with the Malta Medicines Authority.

Conditions
  • As at 15 September 2026, EUDAMED's mandatory use is imminent: Commission Decision (EU) 2025/2371 of 26 November 2025 (published 27 November 2025) confirmed that the Actors, UDI and devices, Notified bodies and certificates, and Market surveillance modules are functional, and under MDR Art. 123(3) the related obligations apply six months after publication of that notice; the Malta Medicines Authority states the mandatory start date as 28 May 2026.
  • The Basic UDI-DI is the fee unit for a device notification: the fee is quoted per Basic UDI-DI device.
  • Devices bearing the same Basic UDI-DI are treated as variants of one device for notification purposes.

Effective from 2026-02-01

Source language: English. Verbatim: 'Basic UDI-DI: Where applicable, the Basic UDI-DI of the medical device as written on the DoC. UDI-DI: Where applicable, the UDI-DI of the medical device as written on the DoC.' The SRN requirement is verbatim from the same guidance: 'SRN refers to, if applicable, the Single Registration Number generated by EUDAMED.' The EUDAMED actor-registration duty for importers is stated in the Authority's Factsheet for Importers & Distributors (res-mt-mma-factsheet-importers): 'Register as an actor in EUDAMED'.

Vigilance & incident reporting

What is reportable, by whom, where, in what format, and by what deadline?

Compare countries

Economic operators must immediately forward incident reports to the competent authority

vigilance.economic-operator-must-forward-incident-reports
Fact-level verified

Any economic operator that receives complaints or reports from healthcare professionals, patients or users about incidents related to a medical device it has made available on the local market must immediately forward that information to the competent authority — the Medicines Authority. Every economic operator must also keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and keep the Authority informed of that monitoring. The Authority may request any further information it deems necessary. The national vigilance channel is mdvigilance.medicinesauthority@gov.mt, and the Authority publishes device incident report forms for healthcare professionals and for the general public.

Conditions
  • Union-side parallel duty: manufacturers report serious incidents and field safety corrective actions through the electronic system under MDR Art. 87, with the Maltese Authority as the relevant competent authority.
  • Contravention of S.L. 458.59 is an offence carrying a fine of EUR 12,000 to EUR 120,000, imprisonment up to two years, or both.

Effective from 2020-08-04

Source language: English. Verbatim reg. 10(1): 'Any economic operator that has received complaints or reports from healthcare professionals, patients or users about incidents related to a medical device which they have made available on the local market, shall immediately forward this information to the competent authority.' Verbatim reg. 10(2): 'Every economic operator shall keep a register containing details of complaints, of non-conforming medical devices and of recalls and withdrawals of medical devices, and shall keep the competent authority informed of such monitoring.' The vigilance mailbox and the incident report forms are published by the Authority (res-mt-mma-medical-devices).

Manufacturer reporting deadlines: 15 days, or 2 days for a serious public health threat

vigilance.manufacturer-reporting-deadlines
Fact-level verified

Manufacturers of devices made available on the Union market must report to the relevant competent authorities any serious incident involving such a device, and any field safety corrective action in respect of such a device — including a corrective action undertaken in a third country where the reason is not limited to the device made available there. A serious incident must be reported immediately after the manufacturer establishes that a causal relationship with its device is established or reasonably possible, and no later than 15 days after it becomes aware of the incident. In the event of a serious public health threat the report must be provided immediately and no later than 2 days after the manufacturer becomes aware of that threat. Reports are submitted through the electronic system under MDR Art. 92.

Conditions
  • IVDR mirror: Articles 82-84, Regulation (EU) 2017/746.
  • Trend reporting of statistically significant increases in non-serious incidents is separate (MDR Art. 88).
  • The Maltese Authority is the relevant competent authority for devices it supervises and operates the national vigilance mailbox.

Effective from 2021-05-26

Verbatim Art. 87(3): 'Manufacturers shall report any serious incident as referred to in point (a) of paragraph 1 immediately after they have established the causal relationship between that incident and their device or that such causal relationship is reasonably possible and not later than 15 days after they become aware of the incident.' Verbatim Art. 87(4): 'Notwithstanding paragraph 3, in the event of a serious public health threat the report referred to in paragraph 1 shall be provided immediately, and not later than 2 days after the manufacturer becomes aware of that threat.'

Related structured datasets

Classification systems · 2 records
Open EU IVDR classes A, B, C and D →
Id

malta:ivd

Jurisdiction Id

malta

Domains
  • ivd
Name

EU IVDR classes A, B, C and D

Description

National projection of the directly applicable EU IVDR classification. The canonical class axis and rules are maintained in eu:ivd, and the Maltese instruments apply the IVDR classes as such rather than renaming them: S.L. 458.59 defines 'in-vitro diagnostic medical device' only by reference to paragraph 2 of Article 2 of Regulation (EU) 2017/746 and adds no national class axis, so the class labels here are the canonical IVD Class A to IVD Class D. The Maltese references describe only administration and the national registration overlay.

Classes
  • Id

    a

    Label

    IVD Class A

    Normalized Risk Level

    low

  • Id

    b

    Label

    IVD Class B

    Normalized Risk Level

    medium

  • Id

    c

    Label

    IVD Class C

    Normalized Risk Level

    high

  • Id

    d

    Label

    IVD Class D

    Normalized Risk Level

    highest

Regulator

Medicines Authority

Official Domains
  • medicinesauthority.gov.mt
  • legislation.mt
  • eur-lex.europa.eu
Source Status

official-source-verified

Reference Sources
  • Title

    Medical Devices and In-Vitro Diagnostic Medical Devices Provision on the Maltese Market Regulations, S.L. 458.59 (L.N. 321 of 2020)

    Url

    https://legislation.mt/eli/sl/458.59/eng

    Reviewed On

    2026-09-16

    Supports

    The regulation treats in-vitro diagnostic medical devices inside the same single national regime as medical devices — the title covers both, the definition of 'in-vitro diagnostic medical device' is the IVDR Article 2(2) definition, and the registration conditions of regulation 5 (registered person in Malta, local device details entered in the national medical device database) are drafted for devices generally rather than for one of the two Regulations.

Inherited From Scheme Id

eu:ivd

Source Title

Regulation (EU) 2017/746 on in vitro diagnostic medical devices, Art. 47 and Annex VIII

Source Url

https://eur-lex.europa.eu/eli/reg/2017/746/oj

Verified On

2026-09-16

Source Supports
  • class-axis
  • classification-rules
Open EU MDR classes I, Is, Im, Ir, IIa, IIb and III →
Id

malta:medical-device

Jurisdiction Id

malta

Domains
  • medical-device
Name

EU MDR classes I, Is, Im, Ir, IIa, IIb and III

Description

National projection of the directly applicable EU MDR classification. The canonical class axis and rules are maintained in eu:medical-device; the Maltese references describe only administration, the national registration overlay and the optional paid classification-confirmation service.

Classes
  • Id

    i

    Label

    Class I

    Normalized Risk Level

    low

  • Id

    is

    Label

    Class Is

    Normalized Risk Level

    low

  • Id

    im

    Label

    Class Im

    Normalized Risk Level

    low

  • Id

    ir

    Label

    Class Ir

    Normalized Risk Level

    low

  • Id

    iia

    Label

    Class IIa

    Normalized Risk Level

    medium

  • Id

    iib

    Label

    Class IIb

    Normalized Risk Level

    high

  • Id

    iii

    Label

    Class III

    Normalized Risk Level

    highest

Regulator

Medicines Authority

Official Domains
  • medicinesauthority.gov.mt
  • legislation.mt
  • eur-lex.europa.eu
Source Status

official-source-verified

Reference Sources
  • Title

    Medical Devices and In-Vitro Diagnostic Medical Devices Provision on the Maltese Market Regulations, S.L. 458.59 (L.N. 321 of 2020)

    Url

    https://legislation.mt/eli/sl/458.59/eng

    Reviewed On

    2026-09-16

    Supports

    The national overlay adds no class axis: 'competent authority' is defined as the Medicines Authority (Cap. 458) and 'medical device' and 'in-vitro diagnostic medical device' are defined only by reference to paragraph 1 of Article 2 of Regulation (EU) 2017/745 and paragraph 2 of Article 2 of Regulation (EU) 2017/746, so the class is the Union class. What the regulations add is registration-side: regulation 5(f) requires the operator to have a medical device registered person in Malta, regulation 5(g) requires details of every device marketed locally to be inserted in the national medical device database kept by the competent authority, and regulation 6(1) prohibits any person from acting as a medical device registered person unless registered as such with the competent authority.

  • Title

    Medicines Authority (Fees) Regulations, S.L. 458.46, Schedule 5 (added by L.N. 254 of 2025) — risk-classification confirmation service

    Url

    https://legislation.mt/eli/sl/458.46/eng

    Reviewed On

    2026-09-16

    Supports

    Malta publishes a paid, optional classification-confirmation route rather than a mandatory one: Schedule 5 lists 'Request Form for Medical Device / In Vitro Diagnostic confirmation of risk classification' at EUR 1,000, and the note under that group states the processing time is within a 90 working day timeframe from submission of the application and supporting documentation. The service confirms a class; it does not create one.

Inherited From Scheme Id

eu:medical-device

Source Title

Regulation (EU) 2017/745 on medical devices, Art. 51 and Annex VIII

Source Url

https://eur-lex.europa.eu/eli/reg/2017/745/oj

Verified On

2026-09-16

Source Supports
  • class-axis
  • classification-rules
Registration pathways, prior approvals and planning · 1 record
Open Malta registration →
Country

Malta

Jurisdiction Id

malta

Country Code

MT

Flag

🇲🇹

Regulator

Medicines Authority

Regulator Abbrev

Medicines Authority

Region

europe

Tier

3

Risk Classification

4-class (I, IIa, IIb, III) — EU MDR

Classes
  • Id

    class-i

    Class Name

    Class I

    Risk Level

    low

    Pathway

    Self-declaration (no notified body)

    Official Timeline
    Min

    0

    Max

    0

    Unit

    days

    Verification Status

    official-verified

    Official Source
    Title

    EUR-Lex Regulation (EU) 2017/745 (MDR)

    Url

    https://eur-lex.europa.eu/eli/reg/2017/745/oj

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    6

    Max

    9

    Notes
    • MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock
    • Elapsed time is Eudamed actor and device registration, which has no guaranteed processing time, plus the Maltese national registration duties in S.L. 458.59
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

  • Id

    malta-national-organisation-and-device-registration

    Class Name

    Maltese organisation registration, device registration and free-sale certificate — standard service

    Risk Level

    low

    Pathway

    National registration under S.L. 458.59, processed under the Schedule 5 standard service

    Official Timeline
    Min

    30

    Max

    30

    Unit

    days

    Verification Status

    official-verified

    Official Source
    Title

    Medicines Authority (Fees) Regulations, S.L. 458.46, Schedule 5 (added by L.N. 254 of 2025) — the 30-working-day standard service, the 10-working-day fast-track and the 90-working-day notes

    Url

    https://legislation.mt/eli/sl/458.46/eng

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    30

    Max

    60

    Unit

    days

    Notes
    • This is the national competent-authority clock, not the conformity-assessment clock: Schedule 5 of S.L. 458.46 fixes a standard service of 30 working days from the date of submission of the application and supporting documentation, and the distributor/importer organisation registration, the certificate of free sale and the device registration lines all sit under it
    • Those lines carry the fast-track asterisk, so the applicant may instead buy a 10-working-day service at double the fee
    • The period is interrupted if the Authority requests further information or clarification and recommences on receipt of the applicant's response, which is why the realistic range is wider than the published clock
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    No

  • Id

    malta-derogation-application

    Class Name

    National derogation (MDR Art. 59 and 97, IVDR Art. 54 and 92) — application and renewal

    Risk Level

    high

    Pathway

    Medicines Authority derogation under S.L. 458.46 Schedule 5

    Official Timeline
    Min

    90

    Max

    90

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    Medicines Authority (Fees) Regulations, S.L. 458.46, Schedule 5 (added by L.N. 254 of 2025) — the 30-working-day standard service, the 10-working-day fast-track and the 90-working-day notes

    Url

    https://legislation.mt/eli/sl/458.46/eng

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    3

    Max

    6

    Notes
    • Schedule 5 places the note 'Timeline for the processing of an application is within a 90 working day timeframe' at the end of the Derogations group, in the same position as the group-level notes under the Notified Body, Clinical Investigation and Request-for-advice groups, so it governs the two EUR 1,000 initial derogation lines and the EUR 750 renewal alike
    • The separate 'Application for use of a Non-CE marked medical device in Malta' line (EUR 500) carries no note and falls under the 30-working-day standard service
    • This is the Maltese national clock for a device that has not completed conformity assessment; it is not the Annex IX notified-body clock
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    No

  • Id

    malta-classification-confirmation

    Class Name

    Maltese confirmation of risk classification — advisory service

    Risk Level

    medium

    Pathway

    Optional paid Medicines Authority confirmation under S.L. 458.46 Schedule 5

    Official Timeline
    Min

    90

    Max

    90

    Unit

    days

    Verification Status

    official-verified

    Official Source
    Title

    Medicines Authority (Fees) Regulations, S.L. 458.46, Schedule 5 (added by L.N. 254 of 2025) — the 30-working-day standard service, the 10-working-day fast-track and the 90-working-day notes

    Url

    https://legislation.mt/eli/sl/458.46/eng

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    3

    Max

    4

    Notes
    • Schedule 5 lists the request form for medical device or in-vitro diagnostic confirmation of risk classification at EUR 1,000 under a note fixing the processing time within a 90 working day timeframe from date of submission of the application and supporting documentation
    • The service is optional and confirms the Union class; it is not a prerequisite for placing a device on the Maltese market and it does not replace the manufacturer's own Annex VIII classification
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    No

Prior Approvals
  • Authority

    FDA 510(k)/PMA

    Accepted

    No

    Benefit

    No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

Key Requirements
  • EU Authorized Representative (for non-EU manufacturers)
  • Medicines Authority organisation registration of the distributor or importer — initial application, EUR 500 standard service
  • A medical device registered person established in Malta and registered with the Medicines Authority (S.L. 458.59 regulation 5(f) and regulation 6(1))
  • Details of every device marketed locally entered in the national medical device database kept by the Medicines Authority (S.L. 458.59 regulation 5(g))
  • EUDAMED actor registration, with the first four EUDAMED modules mandatory since 28 May 2026
  • English and Maltese are both official languages of Malta and the Maltese market is served in English; no separate Maltese-language IFU instrument was located in the medical device subsidiary legislation
  • Medical equipment emitting ionizing radiation also needs the Radiation Protection Board authorisation under S.L. 365.15 (Part III and Part XV)
Local Rep Required

Yes

Local Rep Name

EU Authorized Representative

Mdsap Accepted

No

Mdsap Benefit

ISO 13485 accepted as QMS evidence

Registration Validity

5 years (CE certificate)

Last Updated

2026-09-16

Verification Status

partially-verified

Official Sources
  • Title

    EUR-Lex Regulation (EU) 2017/745 (MDR)

    Url

    https://eur-lex.europa.eu/eli/reg/2017/745/oj

    Accessed Date

    2026-09-16

  • Title

    MDR Annex IX — conformity assessment based on a quality management system and on assessment of technical documentation (§5.1 expert-panel consultations, §5.2(d) medicinal-products authority opinion)

    Url

    https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02017R0745-20250110

    Accessed Date

    2026-09-16

  • Title

    Commission Implementing Regulation (EU) 2026/977, Art. 2 — maximum notified-body conformity assessment timelines (30 + 120/90 parallel + 20 days)

    Url

    https://eur-lex.europa.eu/eli/reg_impl/2026/977/oj

    Effective Date

    2027-02-25

    Accessed Date

    2026-09-16

  • Title

    Medicines Authority (Fees) Regulations, S.L. 458.46, Schedule 5 (added by L.N. 254 of 2025) — the 30-working-day standard service, the 10-working-day fast-track and the 90-working-day notes

    Url

    https://legislation.mt/eli/sl/458.46/eng

    Accessed Date

    2026-09-16

  • Title

    Medical Devices and In-Vitro Diagnostic Medical Devices Provision on the Maltese Market Regulations, S.L. 458.59 (L.N. 321 of 2020) — competent authority, registered person and national medical device database

    Url

    https://legislation.mt/eli/sl/458.59/eng

    Accessed Date

    2026-09-16

Reviewed On

2026-09-16

Process
Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps
  • Step

    1

    Title

    Pre-Submission Preparation

    Description

    Gather technical documentation, quality management system (QMS) records, and clinical data required by Medicines Authority. Appoint a EU Authorized Representative.

    Duration

    1-3 months

    Icon

    📋

  • Step

    2

    Title

    Application Submission

    Description

    Submit complete registration dossier to Medicines Authority including device description, risk analysis, and testing reports.

    Duration

    1-2 weeks

    Icon

    📤

  • Step

    3

    Title

    Administrative Review

    Description

    Medicines Authority reviews application for completeness. May request additional documents or clarifications.

    Duration

    2-4 weeks

    Icon

    🔍

  • Step

    4

    Title

    Technical Evaluation

    Description

    In-depth technical assessment of device safety and performance. Medicines Authority may issue questions.

    Duration

    0 days

    Icon

    ⚙️

  • Step

    5

    Title

    Registration Approval

    Description

    Upon successful review, Medicines Authority issues Malta market authorization certificate.

    Duration

    1-2 weeks

    Icon

    ✅

Government fee schedules · 1 record
Open Malta fees →
Jurisdiction Id

malta

Country

Malta

Country Code

MT

Authority

Medicines Authority

Low Risk Local
Min

100

Max

500

Currency

EUR

Per Product

No

High Risk Local
Min

1000

Max

5000

Currency

EUR

Per Product

No

Details
  • Id

    distributor-importer-organisation-registration

    Item

    Initial application for organisation registration of distributor/importer

    Currency

    EUR

    Amount Local

    500

    Amount Local Formatted

    EUR 500

    Frequency

    Per application

    Notes

    Schedule 5, Distributor / Importer group. Carries the fast-track asterisk: fast-track service is offered at double the original fee, i.e. EUR 1,000, for completion within a 10 working day timeframe.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://legislation.mt/eli/sl/458.46/eng

    Source Title

    Medicines Authority (Fees) Regulations, S.L. 458.46 (L.N. 315 of 2006, as amended), Schedule 5 — Fees related to Medical Devices and In Vitro Diagnostic Medical Devices, added by L.N. 254 of 2025

    Verified On

    2026-09-16

  • Id

    certificate-of-free-sale

    Item

    Certificate of Free Sale application

    Currency

    EUR

    Amount Local

    250

    Amount Local Formatted

    EUR 250

    Frequency

    Per declaration of conformity

    Notes

    Schedule 5, Distributor / Importer group. Fast-track eligible at double the fee.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://legislation.mt/eli/sl/458.46/eng

    Source Title

    Medicines Authority (Fees) Regulations, S.L. 458.46 (L.N. 315 of 2006, as amended), Schedule 5 — Fees related to Medical Devices and In Vitro Diagnostic Medical Devices, added by L.N. 254 of 2025

    Verified On

    2026-09-16

  • Id

    device-registration-european-market

    Item

    Device Registration — placing a medical device on the European market application

    Currency

    EUR

    Amount Local

    100

    Amount Local Formatted

    EUR 100

    Frequency

    Per declaration of conformity

    Notes

    Schedule 5, Device Registration in the European Market group. The amending registration (revised) line is published at the same EUR 100; withdrawal incurs no charge. Fast-track eligible at double the fee.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://legislation.mt/eli/sl/458.46/eng

    Source Title

    Medicines Authority (Fees) Regulations, S.L. 458.46 (L.N. 315 of 2006, as amended), Schedule 5 — Fees related to Medical Devices and In Vitro Diagnostic Medical Devices, added by L.N. 254 of 2025

    Verified On

    2026-09-16

  • Id

    derogation-article-59-mdr-article-54-ivdr

    Item

    Derogation application in terms of Article 59 of Regulation (EU) 2017/745 and Article 54 of Regulation (EU) 2017/746

    Currency

    EUR

    Amount Local

    1000

    Amount Local Formatted

    EUR 1,000

    Frequency

    Per application

    Notes

    Schedule 5, Derogations group — the public-health derogation route onto the Maltese market for a device that has not completed the applicable conformity assessment.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://legislation.mt/eli/sl/458.46/eng

    Source Title

    Medicines Authority (Fees) Regulations, S.L. 458.46 (L.N. 315 of 2006, as amended), Schedule 5 — Fees related to Medical Devices and In Vitro Diagnostic Medical Devices, added by L.N. 254 of 2025

    Verified On

    2026-09-16

  • Id

    derogation-article-97-mdr-article-92-ivdr

    Item

    Derogation application in terms of Article 97 of Regulation (EU) 2017/745 and Article 92 of Regulation (EU) 2017/746

    Currency

    EUR

    Amount Local

    1000

    Amount Local Formatted

    EUR 1,000

    Frequency

    Per application

    Notes

    Schedule 5, Derogations group — the national competent-authority derogation for a device that is not compliant but whose use is in the interest of public health or patient safety in Malta.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://legislation.mt/eli/sl/458.46/eng

    Source Title

    Medicines Authority (Fees) Regulations, S.L. 458.46 (L.N. 315 of 2006, as amended), Schedule 5 — Fees related to Medical Devices and In Vitro Diagnostic Medical Devices, added by L.N. 254 of 2025

    Verified On

    2026-09-16

  • Id

    derogation-renewal

    Item

    MDR and IVDR derogation renewal

    Currency

    EUR

    Amount Local

    750

    Amount Local Formatted

    EUR 750

    Frequency

    Per renewal

    Notes

    Schedule 5 publishes this as a separate line at EUR 750 under a note fixing the processing time within a 90 working day timeframe from date of submission of the application and supporting documentation. This is a lower figure than the EUR 1,000 initial application and is the kind of exact-wording item that is easy to miss.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://legislation.mt/eli/sl/458.46/eng

    Source Title

    Medicines Authority (Fees) Regulations, S.L. 458.46 (L.N. 315 of 2006, as amended), Schedule 5 — Fees related to Medical Devices and In Vitro Diagnostic Medical Devices, added by L.N. 254 of 2025

    Verified On

    2026-09-16

  • Id

    risk-classification-confirmation

    Item

    Request form for medical device / in vitro diagnostic confirmation of risk classification

    Currency

    EUR

    Amount Local

    1000

    Amount Local Formatted

    EUR 1,000

    Frequency

    Per request

    Notes

    Schedule 5, Request for advice group. The note under the group fixes the processing time at 90 working days from submission. The companion request form for advice on making available a device in Malta is EUR 500.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://legislation.mt/eli/sl/458.46/eng

    Source Title

    Medicines Authority (Fees) Regulations, S.L. 458.46 (L.N. 315 of 2006, as amended), Schedule 5 — Fees related to Medical Devices and In Vitro Diagnostic Medical Devices, added by L.N. 254 of 2025

    Verified On

    2026-09-16

  • Id

    pre-submission-meeting-request

    Item

    Pre-submission meeting request application

    Currency

    EUR

    Amount Local

    1000

    Amount Local Formatted

    EUR 1,000

    Frequency

    Per request

    Notes

    Schedule 5, Clinical Investigation / Performance Study group.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://legislation.mt/eli/sl/458.46/eng

    Source Title

    Medicines Authority (Fees) Regulations, S.L. 458.46 (L.N. 315 of 2006, as amended), Schedule 5 — Fees related to Medical Devices and In Vitro Diagnostic Medical Devices, added by L.N. 254 of 2025

    Verified On

    2026-09-16

  • Id

    clinical-investigation-application

    Item

    Application/notification for clinical investigation in accordance with Articles 62 and 74(1) of Regulation (EU) 2017/745

    Currency

    EUR

    Amount Local

    5000

    Amount Local Formatted

    EUR 5,000

    Frequency

    Per application

    Notes

    Schedule 5, Clinical Investigation / Performance Study group. The note under the group states the application timeframe is according to EU legislation and guidance document timelines, so the Maltese 30-working-day standard service does not apply to this line.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://legislation.mt/eli/sl/458.46/eng

    Source Title

    Medicines Authority (Fees) Regulations, S.L. 458.46 (L.N. 315 of 2006, as amended), Schedule 5 — Fees related to Medical Devices and In Vitro Diagnostic Medical Devices, added by L.N. 254 of 2025

    Verified On

    2026-09-16

  • Id

    clinical-investigation-article-82

    Item

    Application/notification for clinical investigation in accordance with Article 82 of Regulation (EU) 2017/745

    Currency

    EUR

    Amount Local

    1000

    Amount Local Formatted

    EUR 1,000

    Frequency

    Per application

    Notes

    Schedule 5, Clinical Investigation / Performance Study group. Article 82 is the additional national provision for a clinical investigation to be conducted in Malta for a device not covered by the MDR's own investigation chapter.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://legislation.mt/eli/sl/458.46/eng

    Source Title

    Medicines Authority (Fees) Regulations, S.L. 458.46 (L.N. 315 of 2006, as amended), Schedule 5 — Fees related to Medical Devices and In Vitro Diagnostic Medical Devices, added by L.N. 254 of 2025

    Verified On

    2026-09-16

  • Id

    performance-study-application

    Item

    Application/notification for performance study in accordance with Regulation (EU) 2017/746

    Currency

    EUR

    Amount Local

    5000

    Amount Local Formatted

    EUR 5,000

    Frequency

    Per application

    Notes

    Schedule 5, Clinical Investigation / Performance Study group. Modification to a clinical investigation or performance study application is EUR 500.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://legislation.mt/eli/sl/458.46/eng

    Source Title

    Medicines Authority (Fees) Regulations, S.L. 458.46 (L.N. 315 of 2006, as amended), Schedule 5 — Fees related to Medical Devices and In Vitro Diagnostic Medical Devices, added by L.N. 254 of 2025

    Verified On

    2026-09-16

  • Id

    non-ce-marked-device-use

    Item

    Application for use of a non-CE marked medical device in Malta

    Currency

    EUR

    Amount Local

    500

    Amount Local Formatted

    EUR 500

    Frequency

    Per application

    Notes

    Schedule 5, Application for use of a Non-CE marked medical device in Malta group.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://legislation.mt/eli/sl/458.46/eng

    Source Title

    Medicines Authority (Fees) Regulations, S.L. 458.46 (L.N. 315 of 2006, as amended), Schedule 5 — Fees related to Medical Devices and In Vitro Diagnostic Medical Devices, added by L.N. 254 of 2025

    Verified On

    2026-09-16

  • Id

    distributor-importer-inspection-letter

    Item

    Inspection letter for distributor/importer

    Currency

    EUR

    Amount Local

    300

    Amount Local Formatted

    EUR 300

    Frequency

    Every 3 years

    Notes

    Schedule 5.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://legislation.mt/eli/sl/458.46/eng

    Source Title

    Medicines Authority (Fees) Regulations, S.L. 458.46 (L.N. 315 of 2006, as amended), Schedule 5 — Fees related to Medical Devices and In Vitro Diagnostic Medical Devices, added by L.N. 254 of 2025

    Verified On

    2026-09-16

  • Id

    notified-body-designation-initial-setup

    Item

    Notified Body Designation application — initial setup of notified body

    Currency

    EUR

    Amount Local

    30000

    Amount Local Formatted

    EUR 30,000

    Frequency

    Per application

    Notes

    Schedule 5. Paid by a conformity assessment body seeking designation by the Medicines Authority rather than by a device manufacturer; published here because it is part of the same Maltese device tariff.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://legislation.mt/eli/sl/458.46/eng

    Source Title

    Medicines Authority (Fees) Regulations, S.L. 458.46 (L.N. 315 of 2006, as amended), Schedule 5 — Fees related to Medical Devices and In Vitro Diagnostic Medical Devices, added by L.N. 254 of 2025

    Verified On

    2026-09-16

Notes
  • Schedule 5 fixes a standard service of 30 working days for the processing of an application from the date of submission of the application and supporting documentation, unless a line carries a different note; if the Authority requires further information or clarification the period is interrupted and recommences on receipt of the applicant's response.
  • Applications marked with an asterisk in Schedule 5 are eligible for fast-track service completed within a 10 working day timeframe, charged at double the original fee.
  • All fees under Schedule 5 are non-refundable.
  • The low-risk band is the published spread between the EUR 100 device registration line and the EUR 500 distributor/importer organisation registration line; the high-risk band is the spread between the EUR 1,000 derogation lines and the EUR 5,000 clinical investigation and performance study lines. Both bands are per application or per declaration of conformity, not per unit, and the bands are the reporter's grouping of published line items rather than a figure printed by the Medicines Authority.
  • The clinical investigation and performance study lines are expressly excluded from the 30-working-day standard service and follow EU legislation and guidance document timelines instead.
Last Updated

2026-09-16

Verification Status

official-verified

Official Sources
  • Title

    Medicines Authority (Fees) Regulations, S.L. 458.46 (L.N. 315 of 2006, as amended), Schedule 5 — Fees related to Medical Devices and In Vitro Diagnostic Medical Devices, added by L.N. 254 of 2025

    Url

    https://legislation.mt/eli/sl/458.46/eng

    Accessed Date

    2026-09-16

Reviewed On

2026-09-16

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record
Open Malta certifications →
Slug

malta

Market

Malta

Confidence

high

Schemes
  • Id

    lvd-medical-equipment-outside-scope

    Name

    Medical and radiology electrical equipment outside the Low Voltage Regulations

    Category

    Medical Electrical Safety

    Status

    Included In Medical Registration

    Object

    Finished Device

    Note

    Malta implements Directive 2014/35/EU through the Low Voltage Electrical Equipment Regulations, S.L. 427.34 (L.N. 97 of 2016). Schedule II of those regulations, headed 'Equipment and phenomena outside the scope of these regulations', lists 'Electrical equipment for radiology and medical purposes', so a medical device attracts no separate Maltese low-voltage certificate. 'The Authority' in the regulations is the Malta Competition and Consumer Affairs Authority (Cap. 510) and the MSD is its Market Surveillance Directorate; the manufacturer's duty to keep technical documentation available to the market surveillance authorities for ten years after placing on the market is in the regulations themselves.

    Source Urls
    • https://legislation.mt/eli/sl/427.34/eng
    Source Binding

    reviewed

  • Id

    emc-maltese-regulations-and-authority

    Name

    Electromagnetic Compatibility Regulations and the MCCAA as market surveillance authority

    Category

    emc

    Status

    Included In Medical Registration

    Object

    Finished Device

    Note

    Malta implements Directive 2014/30/EU through the Electromagnetic Compatibility Regulations, S.L. 427.35 (L.N. 98 of 2016). The regulations designate the MCCAA (Cap. 510) as the authority, define the 'Director General' as the Director General (Technical Regulations) and the MSD as the Market Surveillance Directorate, and make the Technical Regulations Division of the MCCAA the notifying authority for conformity assessment bodies. For a medical device the EMC essential requirements are laid down more specifically by MDR Annex I, so EMC is dossier evidence inside the CE route rather than a separate Maltese conformity step; the regulations' own obligations — technical documentation kept at the disposal of the national authorities for ten years, cooperation with the market surveillance authority — are what remains in the Maltese layer.

    Source Urls
    • https://legislation.mt/eli/sl/427.35/eng
    Source Binding

    reviewed

  • Id

    mccaa-radio-equipment-regulations

    Name

    Radio Equipment Regulations — MCCAA market surveillance in coordination with the MCA

    Category

    Radio Spectrum

    Status

    Mandatory If Feature

    Object

    Radio Equipment

    Note

    Malta implements Directive 2014/53/EU through the Radio Equipment Regulations, S.L. 427.41 (L.N. 213 of 2016, amended by L.N. 7 of 2024 and L.N. 202 of 2025). There is no Maltese type approval: the radio equipment must be constructed to the regulation 4 essential requirements and made available on the market, and regulation 7(2) provides that the Market Surveillance Directorate of the MCCAA, in coordination with the Malta Communications Authority (Cap. 418), may introduce conditions on putting into service and use. Two medical-device-specific provisions matter. Regulation 4(10) disapplies the essential requirements of regulation 4(3)(d), (e) and (f) for radio equipment to which Regulation (EU) 2017/745 or Regulation (EU) 2017/746 also applies, and regulation 4(11) disapplies regulation 4(3)(e) and (f) where other Union harmonisation legislation applies. Separately, regulation 6(1) requires manufacturers to register radio equipment types in categories affected by a low level of compliance in the European Commission's central system from 12 June 2018 and to affix the allocated registration number.

    Source Urls
    • https://legislation.mt/eli/sl/427.41/eng
    Source Binding

    reviewed

  • Id

    rohs-mccaa-competent-authority

    Name

    Restriction of Hazardous Substances Regulations — MCCAA competent authority

    Category

    Environmental And Batteries

    Status

    Evidence Only No Separate Certificate

    Object

    Electrical Electronic Medical Device

    Note

    Malta implements Directive 2011/65/EU through the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations, S.L. 427.57 (L.N. 84 of 2013, as amended). The competent authority named in the regulations is the Malta Competition and Consumer Affairs Authority (Cap. 510). Regulation 4(3) applies the restrictions to medical devices from 22 July 2014 and to in-vitro diagnostic medical devices from 22 July 2016, while the scope exclusions include active implantable medical devices, so RoHS is a compliance obligation evidenced in the technical file rather than a separate Maltese certificate. The regulations also cross-refer the medical-device definitions to the Maltese medical-device subsidiary legislation.

    Source Urls
    • https://legislation.mt/eli/sl/427.57/eng
    Source Binding

    reviewed

  • Id

    weee-producer-responsibility-era

    Name

    WEEE producer responsibility under the Environment and Resources Authority

    Category

    Environmental And Batteries

    Status

    Mandatory Pre Market

    Object

    Producer Or Authorised Representative

    Note

    Malta implements Directive 2012/19/EU through the Waste Management (Electrical and Electronic Equipment) Regulations, S.L. 549.89 (L.N. 204 of 2014, as amended by L.N. 232 of 2015, L.N. 148 and 455 of 2021, L.N. 200 of 2025 and L.N. 163 of 2026). The 'competent authority' is defined by reference to the Environment Protection Act (Cap. 549), i.e. the Environment and Resources Authority. Producers of electrical and electronic equipment placed on the Maltese market carry the extended-producer-responsibility duties in the regulations — separate collection, treatment, recovery and environmentally sound disposal financed by the producer, with the financial guarantee provided for in the regulations — and the Authority may appoint operators to run the collection schemes. This is a producer-side pre-market registration and financing duty, not a device certificate.

    Source Urls
    • https://legislation.mt/eli/sl/549.89/eng
    Source Binding

    reviewed

  • Id

    batteries-regulation-2023-1542-chapter-viii-malta

    Name

    Battery producer registration under Regulation (EU) 2023/1542 Chapter VIII

    Category

    Environmental And Batteries

    Status

    Mandatory Pre Market

    Object

    Battery Producer Or Authorised Representative

    Note

    Malta gave effect to Chapter VIII of Regulation (EU) 2023/1542 by A.L. 232 of 2025, the Waste Management (Waste Batteries) Regulations made under articles 54 and 55 of the Environment Protection Act (Cap. 549) and published in Supplement B of the Government Gazette No. 21,520 of 14 October 2025, which repealed the earlier batteries subsidiary legislation. Regulation 3 of that instrument designates the Environment and Resources Authority as the competent authority responsible for implementing the obligations established in Chapter VIII of Regulation (EU) 2023/1542, and regulation 4 requires a producer to appoint an authorised representative for extended producer responsibility for batteries sold to end users in Malta by written mandate. The instrument itself was read from the Gazette; no stable https locator for it could be confirmed, so this row is bound to the Union regulation and the Maltese instrument is cited by its gazette reference only.

    Source Urls
    • https://eur-lex.europa.eu/eli/reg/2023/1542/oj
    Source Binding

    candidate

  • Id

    radiation-protection-board-nuclear-safety

    Name

    Nuclear Safety and Radiation Protection Regulations — Radiation Protection Board

    Category

    Ionizing Radiation

    Status

    Mandatory For Use Site

    Object

    Radiation Equipment Source And Use Site

    Note

    Malta's radiation instrument is the Nuclear Safety and Radiation Protection Regulations, S.L. 365.15 (L.N. 44 of 2003, as amended by L.N. 173 of 2004, L.N. 425 of 2007, Act XV of 2009, L.N. 426 of 2012, L.N. 210 of 2018 and Act XXXIII of 2024). Part III establishes the Radiation Protection Board with the power to receive notifications and issue authorisations; Parts IV to XIV were deleted by L.N. 210 of 2018; Part XV then places the operating duties on the radiation employer — regulation 60 makes the employer responsible for the safety of sources from acquisition to final disposal, regulation 61 requires the employer, with suppliers, to ensure on procurement that equipment containing a radiation generator conforms to the international standards the Board approves and is tested against them, and regulations 62 and 63 govern accounting for and keeping of radioactive substances. Because Parts IV to XIV (regulations 17 to 59) were deleted by L.N. 210 of 2018, the former notification regulations 17 and 18 no longer exist in the instrument, although the schedule headings still refer to regulation 17. The instrument carries the note that it has been transferred to Cap. 653 as S.L. 653.05 (Act XXXV of 2025), so S.L. 365.15 is its historic number. The regime therefore bites at the Maltese site where the equipment is held and used, not as a device-level pre-market certificate and not as a Medicines Authority function.

    Source Urls
    • https://legislation.mt/eli/sl/365.15/eng
    Source Binding

    reviewed

Official Sources
  • Authority

    Malta Competition and Consumer Affairs Authority

    Topic

    Low Voltage Electrical Equipment Regulations S.L. 427.34 (L.N. 97 of 2016) — Schedule II excludes electrical equipment for radiology and medical purposes

    Url

    https://legislation.mt/eli/sl/427.34/eng

  • Authority

    Malta Competition and Consumer Affairs Authority

    Topic

    Electromagnetic Compatibility Regulations S.L. 427.35 (L.N. 98 of 2016) — MSD, Director General (Technical Regulations) and TRD as notifying authority

    Url

    https://legislation.mt/eli/sl/427.35/eng

  • Authority

    Malta Competition and Consumer Affairs Authority / Malta Communications Authority

    Topic

    Radio Equipment Regulations S.L. 427.41 (L.N. 213 of 2016) — medical-device derogations in regulation 4(10) and (11), MSD in coordination with the MCA

    Url

    https://legislation.mt/eli/sl/427.41/eng

  • Authority

    Malta Competition and Consumer Affairs Authority

    Topic

    Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations S.L. 427.57 (L.N. 84 of 2013)

    Url

    https://legislation.mt/eli/sl/427.57/eng

  • Authority

    Environment and Resources Authority

    Topic

    Waste Management (Electrical and Electronic Equipment) Regulations S.L. 549.89 (L.N. 204 of 2014, as amended)

    Url

    https://legislation.mt/eli/sl/549.89/eng

  • Authority

    EUR-Lex

    Topic

    Regulation (EU) 2023/1542 on batteries and waste batteries, Chapter VIII — producer registration and authorised representative

    Url

    https://eur-lex.europa.eu/eli/reg/2023/1542/oj

  • Authority

    Radiation Protection Board

    Topic

    Nuclear Safety and Radiation Protection Regulations S.L. 365.15 (L.N. 44 of 2003, as amended)

    Url

    https://legislation.mt/eli/sl/365.15/eng

  • Authority

    Medicines Authority

    Topic

    Medical Devices and In-Vitro Diagnostic Medical Devices Provision on the Maltese Market Regulations S.L. 458.59 (L.N. 321 of 2020)

    Url

    https://legislation.mt/eli/sl/458.59/eng

  • Authority

    Medicines Authority

    Topic

    Medicines Authority (Fees) Regulations S.L. 458.46 — Schedule 5, fees related to medical devices and in vitro diagnostic medical devices

    Url

    https://legislation.mt/eli/sl/458.46/eng

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