Medical devices in Great Britain are regulated under the Medical Devices Regulations 2002 (UK MDR 2002), enforced by the Medicines and Healthcare products Regulatory Agency (MHRA). Northern Ireland follows the EU Medical Devices Regulation (EU MDR) and In Vitro Diagnostic Regulation (EU IVDR) instead. The Great Britain framework is in the middle of a staged overhaul. New post-market surveillance rules have applied since 16 June 2025. A draft package of pre-market changes, the Medical Devices (Amendment) Regulations 2026, was published in May 2026 and is expected to apply from mid-2027, subject to Parliament.

This guide explains how the rules work today, what is changing, and what the changes mean for clinical and biomedical engineering teams and for manufacturers supplying the UK.

Who regulates medical devices in the UK?

The MHRA is the regulator for medical devices across the UK. The rules it applies depend on where in the UK a device is placed on the market:

The rest of this guide focuses on Great Britain, where most of the recent and upcoming change applies.

The UK MDR 2002 explained

The UK MDR 2002 is the core legislation for medical devices in Great Britain. It was originally written to implement three EU directives: the Medical Devices Directive (MDD), the Active Implantable Medical Devices Directive (AIMDD) and the In Vitro Diagnostic Medical Devices Directive (IVDD).

When the UK left the EU, the newer EU MDR and IVDR did not carry over into Great Britain law. As a result, the Great Britain rules are still built on the older directive-based framework, amended since then. The Medicines and Medical Devices Act 2021 gives the government powers to update them, and the amendments described below are being made that way.

The current consolidated text is published on legislation.gov.uk.

CE and UKCA marking: what’s accepted in Great Britain

Devices placed on the Great Britain market need either a UKCA marking or a CE marking, depending on the legislation they were certified under.

UKCA marking shows conformity with the UK MDR 2002. It is valid in Great Britain only; it is not recognised in the EU, the EEA or Northern Ireland. Where third-party assessment is needed, it is carried out by a UK approved body.

CE marking continues to be accepted in Great Britain under transitional arrangements. According to MHRA guidance (last updated 20 February 2026), the deadlines are:

This may change. The MHRA consulted from 16 February to 10 April 2026 on recognising CE-marked devices indefinitely, noting that around 90% of medical devices used in Great Britain are CE marked. As of October 2026, the government’s response had not been published.

Registration and the UK Responsible Person

All medical devices, including IVDs, custom-made devices, and systems or procedure packs, must be registered with the MHRA before they are placed on the Great Britain market.

If the manufacturer is based outside the UK, it must appoint a UK Responsible Person (UKRP). The UKRP acts on the manufacturer’s behalf in the UK. Its duties include:

• registering the manufacturer’s devices with the MHRA;
• keeping technical documentation and declarations of conformity available;
• providing information and samples to the MHRA on request;
• passing on complaints from healthcare professionals and patients;
• cooperating on preventive and corrective actions;
• ending the relationship if the manufacturer acts against its obligations.

Where a device carries UKCA marking, the UKRP’s name and address must appear on the label or instructions for use. Importers and distributors do not need to appoint a UKRP unless they are acting as one.

How medical devices are classified in the UK

Under the UK MDR 2002, general medical devices are classified by risk into Class I, IIa, IIb and III. The class determines the conformity assessment route:

• Class I devices that are non-sterile and have no measuring function can be self-certified by the manufacturer.
• Class I devices that are sterile or have a measuring function, and all higher classes, need assessment by a UK approved body for UKCA marking.

IVDs follow a separate classification structure. The draft 2026 regulations propose revising both the general device and IVD classification rules (see below).

Post-market surveillance: the rules since June 2025

The first major change to the Great Britain framework took effect on 16 June 2025, when the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 came into force. They added a new Part 4A to the UK MDR 2002.

The rules apply to devices placed on the market or put into service in Great Britain from that date, whether they carry CE or UKCA marking. Manufacturers must now:

• collect and assess real-world safety and performance data;
• report serious incidents to the MHRA within 15 days, down from 30;
• submit Field Safety Notices to the MHRA for review before sending them to users;
• provide post-market surveillance reports or periodic safety update reports within 3 days of an MHRA request.

Announcing the change, MHRA Chief Executive Lawrence Tallon said the regulations “provide a robust framework for identifying risks earlier and responding to protect patients”.

What’s coming: the Medical Devices (Amendment) Regulations 2026

The next stage is a set of pre-market changes. The MHRA published the draft Medical Devices (Amendment) Regulations 2026 on the World Trade Organization notification portal on 8 May 2026. It then ran a stakeholder impact survey, which closed on 19 June 2026.

According to legal and regulatory commentators’ analysis of the draft, the main measures are:

• International reliance: routes for devices already authorised by regulators in Australia, Canada and the USA to support access to the Great Britain market.
• Unique device identification (UDI): a mandatory UDI system covering product group, model and production-level data such as lot numbers.
• Revised classification: a more detailed, risk-proportionate classification framework that explicitly covers software, nanomaterials, implantable and invasive devices, and a revised IVD classification aligned with international and EU structures.
• Software as a medical device: cybersecurity requirements and predetermined change control plans.
• Custom-made devices: fuller technical documentation, and quality management system certification for Class IIb and III implantable custom-made devices.
• Other changes: stronger technical documentation requirements, restrictions on misleading claims, and wider eligibility for electronic instructions for use.

When will the new regulations apply?

The regulations still need parliamentary approval, so dates are not final. Latham & Watkins’ analysis of the draft expects adoption in December 2026 and entry into force in June 2027, with the international reliance route following in 2028. Emergo by UL reports transitional periods of three years for medical devices and five years for IVDs.

If those dates hold, the core provisions would start to apply in the same month as EBME Expo 2027.

Key dates at a glance

What the changes mean for clinical and biomedical engineers

For EBME and clinical engineering teams, regulatory change shows up in day-to-day equipment management as well as in procurement:

• Field Safety Notices now pass through MHRA review before reaching users. Teams should still make sure their processes for receiving, assessing and acting on notices are clear, and that they reach the right people across the trust.
• Incident reporting feeds the surveillance system the new rules rely on. In England, Wales and Northern Ireland, healthcare professionals report adverse incidents involving medical devices through the MHRA’s Yellow Card scheme, following their organisation’s local procedures; Scotland has its own reporting route through NHS National Services Scotland. Reporting helps the MHRA and manufacturers identify issues earlier.
• UDI, once introduced, is designed to improve traceability down to lot level. That may support asset management, recalls and implant tracking, depending on how local systems capture it.
• Marking and registration remain relevant to specification and acceptance checks. For the next few years, engineers will see a mix of CE-marked, UKCA-marked and, later, internationally recognised devices.
• Software and connected devices face new cybersecurity and change-control requirements under the draft rules. These may affect how updates to device software are managed and documented.

What the changes mean for manufacturers entering the UK market

For manufacturers, particularly those based outside the UK, the broad route to the Great Britain market currently involves:

1. Confirming the device’s classification under the UK MDR 2002, and whether the product is a medical device at all.
2. Choosing a conformity route: UKCA marking through a UK approved body, or relying on CE marking within the transitional deadlines.
3. Appointing a UK Responsible Person, if the manufacturer is not based in the UK.
4. Registering the device with the MHRA before placing it on the market.
5. Meeting post-market surveillance duties, including the shorter incident-reporting timelines.
6. Planning for the 2026 regulations, including UDI, revised classification and, for devices approved in Australia, Canada or the USA, the international reliance routes.

Regulatory clearance is only one part of UK market entry. Distribution, service support, training and procurement routes all shape whether a device is adopted.

Common questions

What are the UK medical device regulations?

In Great Britain, medical devices are regulated under the Medical Devices Regulations 2002 (UK MDR 2002), as amended, and enforced by the MHRA. Northern Ireland applies the EU MDR and EU IVDR.

What is the UK MDR 2002?

The UK MDR 2002 is the statutory instrument that sets requirements for placing medical devices on the market in Great Britain. It was originally based on EU directives and has been amended since, most recently by the post-market surveillance rules that took effect in June 2025.

Is the UK MDR the same as the EU MDR?

No. The EU MDR replaced the EU directives in 2021, but it did not become Great Britain law. The UK MDR 2002 is still based on the older directives, although the draft 2026 amendments bring parts of it closer to the EU approach, for example on classification.

Are CE-marked devices still accepted in Great Britain?

Yes, currently until 30 June 2028 or 30 June 2030 depending on device type, and subject to certificate expiry for older devices. The MHRA has consulted on accepting CE marking indefinitely; as of October 2026, the government’s response had not been published.

Does a non-UK manufacturer need a UK Responsible Person?

Yes. A manufacturer based outside the UK must appoint a UK Responsible Person to place devices on the Great Britain market.

When do the new UK medical device regulations come in?

The post-market surveillance changes have applied since 16 June 2025. The pre-market changes in the draft Medical Devices (Amendment) Regulations 2026 are expected to come into force in mid-2027 at the earliest, subject to parliamentary approval, with transitional periods after that.

Discuss regulatory change at EBME Expo

Regulatory change affects everyone involved in the medical-equipment lifecycle, from the manufacturers preparing technical files to the engineering teams acting on Field Safety Notices. At EBME Expo 2027 (23–24 June, Coventry Building Society Arena), you can ask manufacturers how they are preparing for the new rules, discuss the practical implications with peers, and hear from professionals working with the regulations every day.

Sources: Regulating medical devices in the UK (MHRA, updated 20 February 2026) · Implementation of the future regulations (MHRA, updated 12 March 2026) · First major overhaul of medical device regulation comes into force across Great Britain (MHRA, 16 June 2025) · Targeted consultation on the indefinite recognition of CE marked devices (MHRA, 2026) · The Yellow Card scheme: guidance for healthcare professionals, patients and the public (MHRA) · The Medical Devices Regulations 2002 · MHRA publishes draft amendment to the UK Medical Devices Regulations (Latham & Watkins, 19 May 2026) · MHRA publishes draft statutory instrument for future regulatory framework (Emergo by UL, 12 May 2026)