UK MDR 2002: what the UK Medical Devices Regulations require now

UK MDR 2002 is the shorthand for the UK Medical Devices Regulations 2002, SI 2002/618, and it is still the law for medical devices and in vitro diagnostics (IVDs) placed on the Great Britain market. It has not been replaced by a new UK regulation. It has been amended in pieces, most recently for post market surveillance in 2025 and fees in 2026, while a much larger reform sits in draft.

That gap between what is law and what is proposed is where most of the bad advice lives. This guide covers how the regulations are structured, how devices are classified under them, what changed in 2025 and 2026, the future regulations programme, the draft 2026 amendments, the indefinite recognition consultation, the Health Bill powers, and the CE acceptance dates that apply today.

What is UK MDR 2002 and how is it structured?

When people talk about the MHRA regulations for devices, this is the instrument they mean. The Medicines and Healthcare products Regulatory Agency (MHRA) enforces it, and the current text on legislation.gov.uk is set out in these Parts:

• Part I: introductory provisions.
• Part II: general medical devices.
• Part III: active implantable medical devices.
• Part IV: in vitro diagnostic medical devices.
• Part 4A: post market surveillance requirements.
• Part V: approved bodies, conformity assessment bodies and marking.
• Part VI: fees.
• Part VII: general, enforcement and miscellaneous provisions.

Two things trip people up. Part IV is IVDs, not post market surveillance. The surveillance rules were inserted as Part 4A, so a reference to “Part 4” for vigilance is a sign someone has not read the current text. And classification still follows the Directive model rather than the EU Medical Device Regulation (EU MDR).

Regulation 7A in Part II is where the UK Responsible Person sits. A manufacturer based outside the UK must appoint a sole UK Responsible Person before placing a device on the Great Britain market. Our complete guide to the UK Responsible Person covers that appointment.

How are devices classified under the UK regulations?

General medical devices in Great Britain are still classified using Annex IX of Directive 93/42/EEC, as modified by Part 2 of Schedule 2A to UK MDR 2002, under regulation 7. They are not classified under Annex VIII of the EU MDR.

In practice this means a device can sit in one class in the EU and a different class in Great Britain. If your technical file was written for the EU MDR, do not assume the class carries across. Work it out again under the rules that apply in Great Britain, then check that the MHRA registration shows the same answer. Our guide to medical device classification sets out where the two systems part company.

What changed in the UK medical device regulations in 2025 and 2026?

Three amendments are in force.

Post market surveillance, from 16 June 2025. The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024, SI 2024/1368, were made and laid on 16 December 2024 and came into force on 16 June 2025. They created Part 4A and apply to UKCA (UK Conformity Assessed) and CE marked devices placed on the Great Britain market, including IVDs and active implantables. The headline changes:

• A mandatory post market surveillance plan, proportionate to risk.
• A post market surveillance report for Class I devices, first within three years of first placing on the market and then at least every three years.
• A periodic safety update report every two years for Class IIa and every year for Class IIb and III. Post market surveillance reports and periodic safety update reports must be made available to the MHRA within 3 working days of a request.
• Serious incidents reported within 15 calendar days of the manufacturer becoming aware, down from 30. A death or unanticipated serious deterioration must be reported within 10 days, and a serious public health threat within 2.
• Trend reporting for statistically significant increases in non serious incidents or expected side effects.
• Serious incident, trend and field safety corrective action reports go through the MHRA MORE portal, and no other channel is accepted.

Assimilated EU law kept, from 24 May 2025. The Medical Devices (Amendment) (Great Britain) Regulations 2025, SI 2025/591, were made on 14 May 2025 and came into force on 24 May 2025. They removed the 25 and 26 May 2025 revocation dates for four pieces of assimilated EU law: Decision 2002/364 on common technical specifications for IVDs, Regulation 207/2012 on electronic instructions for use, Regulation 722/2012 on devices made with animal tissue, and Regulation 920/2013 on notified body designation. Those rules still apply.

Registration fees, from 1 April 2026. The Medical Devices (Fees Amendment) Regulations 2026, SI 2026/197, moved registration to £300 a year per Level 2 category of the Global Medical Device Nomenclature (GMDN). Our MHRA registration guide covers the detail, and our guide to GMDN codes explains how the category is chosen.

What is the future regulations programme?

The government published its responses to the routes to market consultation in two instalments, on 26 February 2025 and 22 July 2025, and said a further statutory instrument would follow in 2026 to introduce new pre market requirements, including international reliance.

The 22 July 2025 response set the direction:

• Four comparable jurisdictions: Australia, Canada, the EU and the USA.
• Reliance Routes 1, 3 and 4 will be implemented. Route 2, for CE marked devices, was deferred. Route 4 was expanded to include software as a medical device (SaMD) and implantable Class IIb and III devices cleared through the US 510(k) route, subject to entire equivalence.
• UKCA marking: the government will remove the requirement to affix the UKCA mark, on condition that the manufacturer assigns a Unique Device Identification (UDI) and the UDI is searchable in a public database. The UDI transitional periods are three years for general devices and five years for IVDs.
• IVD classification: Great Britain moves from the list based system to four risk classes, A, B, C and D, aligned with the International Medical Device Regulators Forum (IMDRF).

None of that is law yet. A government response is a statement of intent. The statutory instrument is what changes your obligations.

What is the Medical Devices (Amendment) Regulations 2026?

It is the draft statutory instrument that would deliver most of that programme. It was published on the World Trade Organization (WTO) notification portal on 8 May 2026. The MHRA’s proposals include:

• International reliance for devices approved in Australia, Canada and the USA.
• Compulsory UDI.
• IVD classification aligned with the IMDRF.
• Implant cards.
• Stronger requirements for keeping technical documentation.
• Traceability for custom made devices.

The MHRA ran a stakeholder impact survey from 11 May to 19 June 2026, and it has closed. As of 25 September 2026 the draft has not been laid before Parliament. Law firm commentary expects it to be laid late in 2026, with commencement in 2027 and the reliance routes later still, but the sources disagree on the months. Treat any date you read as a forecast.

If a supplier, a distributor or a competitor tells you the new pre market rules apply now, they are wrong. You are still working to the current text of SI 2002/618.

Will the UK recognise CE marks indefinitely?

Not under current law. The government ran a targeted consultation from 16 February to 10 April 2026 with three proposals: extend the transitional arrangements for Medical Devices Directive (MDD) devices to match the EU MDR transition timelines, recognise devices compliant with the EU MDR and the EU In Vitro Diagnostic Regulation (EU IVDR) indefinitely, and create an international reliance route for devices classed higher in Great Britain than in the EU. No outcome has been published. The consultation page says the government is analysing the feedback.

Until an outcome is published and then legislated, these dates stand. In the table, AIMDD is the Active Implantable Medical Devices Directive and IVDD the In Vitro Diagnostic Medical Devices Directive.

Topic	Law now (25 September 2026)	Proposed or pending
Legal framework	SI 2002/618 as amended	Draft Medical Devices (Amendment) Regulations 2026, not yet laid
Notified Body certified MDD and AIMDD devices in Great Britain	Accepted until the sooner of certificate expiry or 30 June 2028	Extension consulted on, no outcome
IVDD devices in Great Britain	Accepted until the sooner of certificate expiry or 30 June 2030	No change published
EU MDR and EU IVDR devices in Great Britain	Accepted until 30 June 2030	Indefinite recognition consulted on, no outcome
International reliance	Not available	Routes 1, 3 and 4 for Australia, Canada and the USA. Route 2 for CE marked devices deferred
UKCA mark	Affixed on devices placed through the UKCA route	Requirement to affix removed once UDI is assigned and publicly searchable
UK UDI	Not mandatory	Compulsory, with three year and five year transitions
IVD classification	List based system	Classes A to D, aligned with the IMDRF
Post market surveillance	Part 4A in force since 16 June 2025	Already law

The MHRA adds one exception to the directive dates: they do not apply to Class I devices and general IVDs where neither the directive nor the EU MDR or IVDR requires a Notified Body. For those self declared devices the question is whether they meet the EU MDR or IVDR, so check which group your device falls into before relying on 2028.

If you hold an MDD certificate and your plan depends on an extension, you do not have a plan yet. Our guide to UKCA marking in 2026 sets out the choices.

What does the Health Bill change for medical devices?

On 1 September 2026 the government tabled three amendments to its Health Bill. They include powers to support a future MHRA medical device licensing regime, under which devices placed on the Great Britain market through a domestic route could in future require a licence issued by the MHRA, rather than relying on third party conformity assessment.

Read the qualifier. The government fact sheet of 9 September 2026 says the bill does not itself establish a licensing regime. The MHRA says the UKCA regime will remain in place in Great Britain while any future model is developed. These are enabling powers. The detail would come later, in regulations that do not yet exist.

Where manufacturers go wrong with the UK regulations

• “There is a new UK MDR.” There is not. It is still SI 2002/618, amended.
• “The new pre market rules are law.” A draft was published in May 2026. It has not been laid.
• “CE marks are accepted indefinitely.” That idea went out to consultation and has no published outcome. Current law ends acceptance in 2028 and 2030.
• “UKCA is being scrapped.” The proposal is to remove the requirement to physically affix the mark once UDI is in place. The MHRA says the UKCA regime remains.
• “Post market surveillance changes only apply to UKCA devices.” They apply to CE marked devices on the Great Britain market too.

Where Worldwide Device Solutions fits

We work to the text as it stands today, and we tell clients plainly which parts of their plan rest on law and which rest on a proposal. As your UK Responsible Person, we hold the technical documentation, keep the MHRA registration aligned with it, and handle incident and vigilance reporting on your behalf under a documented agreement, while the legal duty stays with you as the manufacturer. That work draws on 27+ years in global QA and RA (quality assurance and regulatory affairs) and 250+ Notified Body audits delivered.

If you want to know where your devices stand against SI 2002/618 as amended, book a free consultation with Paul. For a structured view of the gaps, our fixed fee Gap Assessment covers it.