MHRA market access

United Kingdom medical device registration resources

Research MHRA registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every United Kingdom medical device resource.

139,339 device-type registration records11 free resources22/25 topics with records17 regulations trackedOct 2026 fees reviewed

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Medical device registration database

Search official MHRA device registration records.

Medical device registry insights

Explore market trends, registrations, manufacturers, and local representatives.

Medical device regulations

Browse official MHRA regulations and guidance documents.

Government registration fees

Review current MHRA application, review, and renewal fees.

AI registration cost and timeline planner

Estimate the likely MHRA pathway, government fees, dossier preparation time, review timeline, and registration steps.

Medical device regulation news

Follow recent MHRA policy, guidance, and compliance updates.

AI medical device classifier

Describe your device and get a preliminary MHRA risk class with an explanation and source links.

Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other United Kingdom requirements.

AI similar registered product finder

Describe a device and find comparable products in the MHRA registration database.

Regulatory requirements data

Browse source-linked lifecycle, language, local-role, renewal, and change-control facts.

Registration timeline

Compare the statutory clocks the Medical Devices Regulations 2002 do fix with the unbounded UK approved body assessment.

Changes after registration

Explore questions and sources →

Common questions about changing a registered medical device in United Kingdom. Each question separates published rules from details still awaiting verification.

Does changing a device brand name or logo require an update? →Source-linked rules available
How do I update a manufacturer's name without changing the legal entity? →Source-linked rules available
What changes when the manufacturer's office address changes? →Source-linked rules available
Does a catalogue or reference code change affect registration or UDI? →Source-linked rules available
Can a registration transfer to a different legal entity? →Source-linked rules available
Can several changes be filed together? →Source-linked rules available

Structured regulatory requirements

Explore all 63 source-linked facts →

22 of 25 research dimensions currently covered · 28 official sources · latest verification 2026-10-26

Market entry

D01

Authority & regime

Verified

Competent authority and enforcement duty: The Medicines and Healthcare products Regulatory Agency (MHRA) operates the UK medical device regime on behalf of the Secretary of State, who has the statutory duty to enforce the Medical D…
Enforcement notice powers: Under the Medicines and Medical Devices Act 2021, MHRA can issue compliance notices, suspension notices, safety notices and information notices to manufacturers and others in the marketing…

2 source-linked facts

Checked 2026-08-25

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D02

Legal basis & guidance

Verified

Core legal regime: Medical devices in the UK are regulated under the Medical Devices Regulations 2002 (SI 2002/618, as amended), comprising Parts for general medical devices, active implantable devices, IVDs,…
Post-market surveillance Part 4A in force: The Medical Devices (Post market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 insert a new Part 4A into SI 2002/618 (regs 44ZC to 44ZN) covering post market surve…

3 source-linked facts

Checked 2026-08-25

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D03

Device definition & scope

Verified

IVD definition: An in vitro diagnostic medical device is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system intended by the manufacturer for in vitro…
Medical device definition: A medical device is any instrument, apparatus, appliance, software, material or other article (including accessories and diagnostic/therapeutic software) intended by the manufacturer for hu…

2 source-linked facts

Checked 2026-08-25

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D04

Classification rules

Verified

GB general medical-device classes I (incl. Is, Im), IIa, IIb and III under the UK MDR 2002.: Class I, Class Is, Class Im, Class IIa, Class IIb, Class III

1 maintained scheme

Checked 2026-08-25

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D05

Registration pathways

Verified

Approved body routes for Class IIa-IIb-III: Class IIa devices follow a manufacturer declaration of conformity combined with an approved body route (product conformity verification, production quality assurance audit, final inspection…
Class I self-declaration route: For Class I medical devices, the manufacturer self declares conformity against the UK MDR 2002 by drawing up a written statement (technical documentation and declaration per Annex VII); for…

4 source-linked facts

Checked 2026-08-25

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D06

Reliance & recognition

Verified

Legacy EU CE under MDD/AIMDD/IVDD - unilateral recognition: CE marked general medical devices certified under the MDD/AIMDD can be placed on the Great Britain market up until the sooner of certificate expiry or 30 June 2028; CE marked IVDs under the…
EU CE under MDR/IVDR - unilateral recognition: Devices CE marked under EU Regulation 2017/745 (MDR) or 2017/746 (IVDR) can be placed on the Great Britain market up until 30 June 2030, with MHRA registration and (for overseas manufacture…

5 source-linked facts

Checked 2026-10-26

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D07

Economic-operator roles

Verified

UK Responsible Person for overseas manufacturers: A manufacturer established outside the UK must appoint a sole UK Responsible Person (UKRP) a person established in any part of the UK acting on behalf of the overseas manufacturer who regis…
A new legal manufacturer is not a same-person rename: The same entity name/address editor excludes a change of legal person. Identify the manufacturer that will take responsibility for conformity and place the affected devices under its name,…

2 source-linked facts

Checked 2026-10-21

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D08

Establishment, import & distribution

Verified

Registration information and statutory fee: A registration under Reg. 7A must include a description of the device and payment of the relevant fee in accordance with regulation 53 of the Medical Devices Regulations 2002; changes to th…
Who must register with MHRA: Registration is required of anyone who sells, leases, lends or gifts devices they made, refurbished or re labelled, systems or procedure packs, custom made devices, and IVDs including those…

2 source-linked facts

Checked 2026-08-25

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D09

Dossier requirements

Verified

Update the CFS source data before an export order: A CFS is an export service requested where the destination requires it, not a routine prerequisite for every identity update. It may be ordered by a UK based manufacturer, UKRP or NI author…
Evidence for the actual DORS change route: For a manufacturer or device registration/re registration, provide the legal entity name and address as shown on the labelling, applicable legislation and class, GMDN, brand, model/version,…

3 source-linked facts

Checked 2026-10-21

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D10

Official forms & portals

Verified

DORS operations have separate sequence constraints: A pending Edit Organisation review blocks certain other account actions. A pending Manage Registered Devices application blocks further updates and CFS orders for its devices. An obsolete G…
Device Online Registration System (DORS): Device registration with MHRA is done through the self service Device Online Registration System (DORS); the applicant must create a DORS account before registering devices and is not regis…

5 source-linked facts

Checked 2026-10-21

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Submission & evidence

D11

Label, IFU & language

Verified

Keep the correct GB and NI label identities: For GB choose the actual UKCA or accepted CE conformity route. When UKCA is affixed, including a dual marked device, the UKRP name and address must be on the product labelling, outer packag…
IVD label identity after a change: For ordinary Northern Ireland devices under the EU regime, the label identifies the device name/trade name and the manufacturer’s name, registered trade name or trademark and registered pla…

6 source-linked facts

Checked 2026-10-21

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D12

QMS, audit & inspection

Verified

UK approved body conformity assessment: Where third party conformity assessment is required for UKCA marking, a UK approved body is needed; approved bodies must be located in the UK, issue the certificates that permit UKCA markin…

1 source-linked fact

Checked 2026-08-25

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D13

Standards, testing & ancillary approvals

Unresolved

UK medical-device conformity and MHRA registration: Electrical safety
Radio Equipment Regulations conformity: Wireless / radio
CE/UKCA conformity marking route: Wireless / radio

4 maintained overlays · 1 related fact

Checked 2026-08-25

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D14

Fees

Unresolved

Medical Device Registration Statutory Fee: £300
Clinical Investigation - Initial/Other Chargeable Submission (Class I, IIa, or IIb other than implantable or long-term invasive): £15,309

12 maintained fee lines · 2 related facts

Checked 2026-10-21

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D15

Review clocks

Unresolved

Class I · Self-declaration (no approved body): 0 days

1 maintained pathway · 1 related fact

Checked 2026-08-29

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D16

Approval validity & renewal

Verified

Authorization duration: There is no fixed duration product registration expiry: market access continues while the accepted conformity route remains valid (UKCA certificate, or CE certificate within the 2028/2030 t…
Renewal or maintenance: The former one off registration fee regime was replaced by an annual fee regime on 1 April 2026. The MHRA guidance captured on 20 October 2026 states that outstanding annual fees for 2026/2…

2 source-linked facts

Checked 2026-10-26

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Lifecycle & post-market

D17

Change control

Verified

Events requiring a new registration: A new registration (potentially with statutory fee) is required for: adding devices in GMDN categories not already on the account; changing device characteristics (wrong GMDN, class, steril…
IVD notified-body change gates: For ordinary Northern Ireland devices under the EU regime, where Annex IX conformity assessment applies, notify the body that approved the QMS of planned substantial QMS or covered device r…

6 source-linked facts

Checked 2026-10-21

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D18

UDI, listing & traceability

Verified

Distinguish registered brand/model from catalogue REF: The current DORS attributes distinguish brand/trade name, model/version, catalogue/REF and UDI. Brand name and model/version are not editable product fields; catalogue/REF is editable. In t…
IVD name/model changes and catalogue REF are distinct: For ordinary Northern Ireland devices under the EU regime, a new UDI DI is required for a change that could cause misidentification or traceability ambiguity, including a device name/trade…

4 source-linked facts

Checked 2026-10-21

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D19

Clinical investigation & performance

Verified

End of investigation and early termination: The manufacturer must notify the Secretary of State of the end of the clinical investigation and justify any premature termination; sponsors must notify MHRA of early termination with justi…
Exception for already-marked devices: Devices already UK marked (CE marked for the Northern Ireland version) do not require clinical investigation notification unless the aim of the intended investigation is to determine whethe…

3 source-linked facts

Checked 2026-08-25

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D20

Special access & derogation

Verified

Exceptional use authorisation: On a duly justified request, in the interests of the protection of health, the Secretary of State may authorise placing devices on the Great Britain market without a UKCA/UK marking, subjec…

1 source-linked fact

Checked 2026-08-25

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D21

Manufacturer PMS

Verified

Periodic safety update report and trend reporting: Manufacturers must produce a periodic safety update report (PSUR): the first within 1 year of placing on the market or putting into service (whichever is sooner) and updates at least every…
Post-market surveillance report (Class I, IVD A/B): Manufacturers of Class I devices (under Directive 93/42, Regulation (EU) 2017/745 or the domestic classification) and IVD class A/B devices not on the Annex II list must produce a post mark…

2 source-linked facts

Checked 2026-08-25

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D22

Vigilance & incident reporting

Verified

Serious incident reporting deadlines (2/10/15 days): The manufacturer must report any serious incident involving its device to the Secretary of State: within 2 days where the incident involves a serious public health threat; within 10 days wh…

1 source-linked fact

Checked 2026-08-25

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D23

Recall, FSCA & market surveillance

Verified

Field safety corrective action and field safety notice: Before taking a field safety corrective action (FSCA) the manufacturer must produce a risk assessment and submit to the Secretary of State an initial report and the proposed field safety no…
Market surveillance, recall and offences: MHRA enforces through MMD Act compliance/suspension/safety/information notices and can recall a device if no alternative steps would sufficiently protect health or safety; enforcement start…

2 source-linked facts

Checked 2026-08-25

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D24

Advertising, claims & promotion

Verified

General advertising/consumer protection regime change: The Consumer Protection from Unfair Trading Regulations 2008 (the general regime covering misleading advertising to consumers, including device advertising) were revoked with effect from 6…

1 source-linked fact

Checked 2026-08-25

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D25

Submission communications & appeal

Verified

CIArb dispute resolution routes: MHRA has appointed the Chartered Institute of Arbitrators (CIArb) as its dispute resolution service for: clinical investigation notifications (UK MDR regs 16 and 29), refusals of clinical i…
Court challenge of MMD Act enforcement notices: A person served with an enforcement notice under the Medicines and Medical Devices Act 2021 may apply to court to revoke or vary the notice within 28 days of the notice being served to a ma…

2 source-linked facts

Checked 2026-08-25

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Government fees

Full fee schedule (12 lines) →

MHRA registration fees in GBP · reviewed 2026-10-21

Fee line	Amount	Provenance
Medical Device Registration Statutory Fee	£300	Verified
Clinical Investigation - Initial/Other Chargeable Submission (Class I, IIa, or IIb other than implantable or long-term invasive)	£15,309	Verified
Clinical Investigation - Initial/Other Chargeable Submission (Class IIb implantable or long-term invasive, III, or active implantable)	£32,016	Verified
Clinical Investigation - Qualifying Resubmission (Class I, IIa, or IIb other than implantable or long-term invasive)	£11,701	Verified

8 more fee lines on the full schedule · 12 of 12 rows source-verified

Registration timeline

Full registration timeline →

Medicines and Healthcare products Regulatory Agency (MHRA) review clocks and planning ranges · 4-class (I, IIa, IIb, III) classification

Class / pathway	Review clock	Planning total	Provenance
Class I(Self-declaration (no approved body)) UK MDR 2002 Part II: Class I devices that are not sterile and have no measuring function are self-declared, so no approved body or MHRA review of the file takes place and no review clock runs Class Is and Im still need a UK approved body for the sterile barrier or the metrological function, and no statutory or published period binds that assessment Registration with the MHRA under reg. 7A is a precondition for placing the device on the GB market, but the DORS service is self-declared and the MHRA guidance publishes no processing time CE mark provides immediate access during transition	0 days	0.5-1 months	Verified

Class / pathway

Review clock

Planning total

Provenance

Class I(Self-declaration (no approved body))

UK MDR 2002 Part II: Class I devices that are not sterile and have no measuring function are self-declared, so no approved body or MHRA review of the file takes place and no review clock runs

Class Is and Im still need a UK approved body for the sterile barrier or the metrological function, and no statutory or published period binds that assessment

Registration with the MHRA under reg. 7A is a precondition for placing the device on the GB market, but the DORS service is self-declared and the MHRA guidance publishes no processing time

CE mark provides immediate access during transition

0 days

0.5-1 months

Verified