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MHRA · Europe

United Kingdom medical device regulatory resources

Every United Kingdom dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

150,962 registration records11 free resources23/25 topics with records9 regulations trackedAug 2026 fees reviewed
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Everything we track for United Kingdom

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.

Structured regulatory requirements

Explore all 45 source-linked facts →

23 of 25 research dimensions currently covered · 14 official sources · latest verification 2026-09-15

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
Open details →
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
Open details →
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
Open details →
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
Open details →
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 2026-09-15
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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…
1 source-linked fact
Checked 2026-08-25
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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
Conformity documentation basis (Annex VII and above)
To affix the UKCA marking, the manufacturer (or its UK responsible person) must fulfil the applicable obligations imposed by Annex VII to the Medical Devices Regulations 2002 including tech…
1 source-linked fact
Checked 2026-08-25
Open details →
D10

Official forms & portals

Verified
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…
Clinical investigation applications via IRAS
Clinical investigation notifications are submitted electronically to MHRA through the Integrated Research Application System (IRAS); applications are validated against MHRA's clinical inves…
2 source-linked facts
Checked 2026-08-25
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Submission & evidence

D11

Label, IFU & language

Verified
English language requirement - general devices
For general medical devices put into service in Great Britain, the label and packaging information requirements (Annex I Sections 8.7 and 13) and the instructions for use requirements (Anne…
English language requirement - IVDs
For in vitro diagnostic medical devices, the information to be provided under Section 8 of Part B of Annex I (labelling and instructions for use) must be in English.
3 source-linked facts
Checked 2026-08-25
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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
Open details →
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
Open details →
D14

Fees

Verified
Medical Device Registration Statutory Fee
£300
Clinical Investigation - Initial Submission (Class I/IIa/IIb non-implantable)
£15,309
12 maintained fee lines · 1 related fact
Checked 2026-08-25
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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/renewal model has been replaced by an annual fee regime: the annual registration fee is GBP 300 per GMDN category (1 April 2026 to 31 March 2027), the paymen…
2 source-linked facts
Checked 2026-08-25
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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…
1 source-linked fact
Checked 2026-08-26
Open details →
D18

UDI, listing & traceability

Verified
UDI in field safety notices and trend reports
A field safety notice must identify the devices and include any unique device identifiers in a searchable format; the initial trend report to the Secretary of State must likewise contain de…
1 source-linked fact
Checked 2026-08-25
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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
Open details →
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
Open details →
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
Open details →
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
Open details →
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
Open details →
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
Open details →
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
Open details →

Government fees

Full fee schedule (12 lines) →

MHRA registration fees in GBP · reviewed 2026-08-25

Fee lineAmountProvenance
Medical Device Registration Statutory Fee£300Verified
Clinical Investigation - Initial Submission (Class I/IIa/IIb non-implantable)£15,309Verified
Clinical Investigation - Initial Submission (Class IIb implantable/long-term invasive, Class III, active implantable)£32,016Verified
Clinical Investigation - Resubmission (Class I/IIa/IIb non-implantable)£11,701Verified
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 / pathwayReview clockPlanning totalProvenance
Class I(Self-declaration (no approved body))0 days0.5-1 monthsVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(0 days)
  5. 5Registration Approval(1-2 weeks)

Latest regulation news

All United Kingdom regulation news →

Newest official MHRA headlines from the daily-refreshed feed — every row links directly to the authority publication.

Sep 14MHMHRAMHRA Field Safety Notices: 7–11 September 2026United KingdomSep 9MHMHRAMHRA Field Safety Notices: 31 August to 4 September 2026United KingdomSep 9MHMHRANational Commission into the Regulation of AI in Healthcare: Recommendations for a Future Regulatory FrameworkUnited KingdomSep 4MHMHRAMHRA-NICE Real-World Evidence Scientific Dialogue ReportUnited KingdomSep 3MHMHRAMHRA Field Safety Notices: 24 to 28 August 2026United Kingdom

Key regulations

All 9 United Kingdom regulations →

Official MHRA rules and guidance · 9 of 9 documents linked to official sources

UK Approved BodiesUK Approved Bodies for Medical Devices
GMP/QMSVerified
MHRA Clinical Investigation GuidanceClinical Investigations of Medical Devices
Clinical TrialsVerified
Future UK Medical Device RegulationsImplementation of Future Medical Device Regulations
RegistrationVerified
SI 2002/618The Medical Devices Regulations 2002
RegistrationVerified

Registry insights

Full registry statistics →

Computed from 150,962 official MHRA registration records · data as of 2025-03-31

New registrations by year
2019202020212022202320242025
VerifiedMHRA registry · as of 2025-03-31
150,962
Registrations
12,675
Manufacturers
1,622
UK Responsible Persons
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United Kingdom market-launch workpaper

Connect the MHRA route, evidence, labels, local role, timing, and dependencies to a wider launch plan.

United Kingdom dossier reuse and delta

Compare an existing authorization and evidence set against MHRA administrative, testing, labeling, and dossier needs.

United Kingdom change notification workpaper

Map a product or manufacturing change to MHRA evidence, notification, timing, and implementation questions.

United Kingdom regulatory change impact

Assess a current MHRA update against one product and turn it into an owner-ready action workpaper.

United Kingdom cybersecurity evidence review

Review connected-device architecture, risks, SBOM, testing, lifecycle controls, and market-specific questions for United Kingdom (MHRA).

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