UK MDR guide to the 2002 rules, PMS duties and coming reform

UK MDR medical device regulations for Great Britain

UK MDR means the Medical Devices Regulations 2002 (SI 2002/618), as amended, which govern medical devices in Great Britain. It differs from the EU MDR: England, Wales and Scotland follow UK MDR 2002, while Northern Ireland follows EU MDR and IVDR.

That split decides which mark you need, where you register and which post-market surveillance (PMS) rules apply.

What the UK MDR 2002 covers

The Medical Devices Regulations 2002 started as the UK implementation of three EU directives: the Medical Devices Directive, the Active Implantable Medical Devices Directive and the In Vitro Diagnostic Medical Devices Directive. The MHRA's overview of UK device regulation, updated 20 February 2026, names the amended 2002 Regulations as the GB framework.

So the 2002 text you find online is only the starting point. It has been amended several times since, including the 2023 extension of CE recognition, the 2024 PMS rules and a 2026 fees amendment that began on 1 April 2026 and added annual registration maintenance fees. Always read the amending instruments alongside the original.

Great Britain and Northern Ireland follow different rules

UKCA alone is not accepted in Northern Ireland, according to the MHRA overview. The registration side changed this year. The MHRA's registration guidance, updated 16 October 2026, says that since 28 May 2026 non-custom-made devices must be registered in EUDAMED before they go on the EU or NI market, and MHRA registration is no longer required for those NI devices. NI importers register in EUDAMED too. Custom-made devices supplied in NI still go to the MHRA, within 28 days of being made available. None of this removes the GB registration duty.

Getting a device onto the GB market

UKCA or CE marking

UKCA is the domestic GB conformity route. Where a device needs an independent conformity assessment, that is done by a UK approved body. Some devices don't need one: eligible Class I devices that are not sterile and have no measuring function, and general IVDs, can be self-declared (MHRA).

CE-marked devices can also be placed on the GB market for now. The 2023 amendment set these outer limits, which are still the law today:

These dates limit new placing on the market. They are not recall dates for units already lawfully supplied (MHRA).

Legacy eligibility has conditions. MDD self-declarations must predate 26 May 2021 (26 May 2022 for the IVDD), and the EU transition conditions must still be met. The extension generally does not cover self-declared devices where neither the old nor the new rules need a notified body. MDD Class I devices that were up-classified under the EU MDR, such as reusable surgical instruments, can qualify. Custom-made devices under the MDD or AIMDD fall outside the directive extension, though compliant EU MDR custom-made devices have their own route (MHRA).

"Certificate expiry" here means when the certificate stops being legally valid, which is not always the date printed on it. An extension under EU MDR Article 120 or IVDR Article 110 can keep a certificate valid, and you must keep evidence of that. EU extensions do not override the GB outer dates (MHRA registration guidance).

MHRA registration and the UK Responsible Person

Medical devices, IVDs, custom-made devices and systems or procedure packs must be registered with the MHRA before they are placed on the GB market. Devices that are only put into service are encouraged, not required, to register. A manufacturer based outside the UK must appoint a single UK Responsible Person (MHRA registration guidance).

Registration is not approval. The MHRA says it isn't accreditation, certification or endorsement. Don't describe a registered device as "MHRA approved".

The UK Responsible Person handles registration, checks and keeps the conformity documents available, cooperates with the MHRA and passes on complaints (MHRA). It's a separate role from an EU authorised representative.

Post-market surveillance rules since June 2025

The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 added a new Part 4A to the UK MDR 2002. The MHRA's PMS guidance gives 16 June 2025 as the start date.

The rules apply per unit, not per model. Any individual device placed on the GB market, or put into service by the manufacturer, on or after 16 June 2025 is covered, whether it carries CE or UKCA marking. Units placed earlier stay under the old PMS rules. But an older model that is still being supplied is not exempt just because its first sale was years ago.

Under Part 4A, manufacturers need a PMS system that is proportionate to risk and built on a documented PMS plan. Custom-made devices have a reduced set of duties. Devices for clinical investigation or performance evaluation, and some exceptional-use authorisations, are excluded.

Part 4A's reporting requirements depend on the device. Custom-made devices are outside these report provisions, and packs have specific exemptions. Count each first report from placing on the market or putting into service, whichever is sooner. If the MHRA requests a relevant PMS plan or report, supply it within three working days, unless an extension is permitted.

• Class I devices, EU IVDR Class A and B devices and IVDs outside the Annex II lists of Directive 98/79 (the old IVD Directive) need a PMS report within three years, then at least every three years.
• Class IIa devices need a periodic safety update report (PSUR) within two years, then at least every two years.
• Other devices subject to PSUR requirements need a report within one year, then at least once a year.

Serious incidents must be reported immediately once a causal link, or a reasonably possible one, is established. The outer limits in regulation 44ZH are 2 days after the manufacturer becomes aware of a serious public health threat, 10 days after awareness of a death or an unanticipated serious deterioration in health, and 15 days after awareness of any other serious incident. These are days, not working days, and they are deadlines, not waiting periods.

Part 4A is GB only. In Northern Ireland, PMS follows the EU MDR and IVDR.

What is changing next

Indefinite recognition of CE-marked devices

On 21 October 2026 the government published its consultation outcome after a consultation that ran from 16 February to 10 April 2026. It intends to change the law so that devices CE-marked under the EU MDR and IVDR are recognised in GB indefinitely, and to align MDD transition periods with EU timelines.

This is a policy decision, not law yet. It needs implementing legislation, and as of 27 October 2026 the 2023 dates in the table above still apply. Plan your certificate work against the current limits until the new instrument is made and in force.

The government announcement also says UKCA stays as the domestic approval route. For CE-marked devices, the UK Responsible Person, registration and GB PMS duties still apply.

Pre-market reform

A wider set of pre-market changes is moving more slowly. MHRA implementation guidance, updated 12 March 2026, said a pre-market statutory instrument would follow in 2026. Planned changes include international reliance on other regulators' approvals, unique device identification (UDI), classification changes, implant cards and stronger technical documentation and essential requirements.

There is a draft. The MHRA announced on 11 May 2026 that the draft Medical Devices (Amendment) Regulations 2026 had been notified to the WTO on 8 May 2026, and a stakeholder impact survey ran from 11 May to 19 June 2026. Neither page gives a start date. Check any proposed date against the final regulations.

The July 2025 consultation response proposed dropping the physical UKCA mark once separate UDI requirements exist. UKCA marking has not been abolished.

Checking a specific device

Whether a given device can stay on the GB market under CE marking depends on its own certificates, class and EU transition status, so check those documents rather than relying on a general table. You can see how RegAffairs AI answers the UK medical device regulations question.

Check the 2026 medical devices instruments on legislation.gov.uk alongside current MHRA guidance. Announced policy does not change the rules until the relevant legislation takes effect.