MHRA Publishes Draft Amendment to the UK Medical Devices Regulations

On 8 May 2026, the UK’s medical devices regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), published its draft amendment to the UK Medical Devices Regulations 2002 — the Medical Devices (Amendment) Regulations 2026 (the Draft Amendment) — on the World Trade Organisation’s (WTO) notification portal for comment by WTO members.

The MHRA has also opened a consultation seeking views on the impact of the Draft Amendment from the medtech industry via a survey. The survey seeks to gather evidence on the practical impact of the Draft Amendment, including likely costs, benefits, and implementation considerations. Responses will inform the impact assessment for the proposed legislation and future implementation.

The Draft Amendment introduces a broad package of pre-market requirements for general medical devices, active implantable medical devices, and in vitro diagnostic medical devices (IVDs) in Great Britain (i.e., England, Scotland, and Wales). In particular, it introduces a new international reliance pathway, the use of unique device identifiers, and more risk-proportionate product classification rules.

Key Proposed Changes

The Draft Amendment would introduce the following changes:

1. International Reliance Pathway

The Draft Amendment introduces an international reliance pathway under which manufacturers of qualifying devices authorised in Australia, Canada, or the United States could use those authorisations to support registration and placement of those devices on the Great Britain market, resulting in accelerated market access.

The international reliance pathway would operate through three routes: Route 1 for the lowest-risk eligible devices, Route 2 for moderate-risk categories, and Route 3 for higher-risk categories. Eligible Route 2 and Route 3 devices would require a Certificate of International Reliance from a UK approved body before registration and placement on the Great Britain market. Route 1 would require only self-declaration and registration (with no UK approved body involvement).

Notably, the list of comparable regulator countries does not include the EU. This is because the UK government is continuing to consider whether to extend recognition of EU CE-marked medical devices in Great Britain indefinitely, as discussed in this recent Latham Client Alert.

2. Unique Device Identifiers

The Draft Amendment introduces a mandatory unique device identifier (UDI) to strengthen traceability. Manufacturers would need to assign a UDI to a device before placing it on the Great Britain market. There would be three components to a UDI, namely: (a) a Basic UDI-DI, which identifies a product group; (b) a UDI-DI, which identifies the manufacturer and device model; and (c) a UDI-PI, which captures production-level information, such as lot numbers, serial numbers, and expiry dates.

Manufacturers would need to: (a) place the UDI on the device itself (or its label) and on all higher levels of its packaging; (b) submit the Basic UDI-DI and the UDI-DI to the MHRA registration system; and (c) include a reference to the UDI in the device’s technical documentation.

3. Risk-Proportionate Product Classification

The Draft Amendment introduces more risk-proportionate classification rules for general medical devices, active implantable medical devices, and IVDs, consistent with International Medical Device Regulators Forum requirements.

For general medical devices and active implantable medical devices, the Draft Amendment introduces a more detailed classification framework, expressly addressing software, nanomaterials, implantable devices, and invasive devices. Broadly, the amendments align the Great Britain classification approach for general medical devices, active implantable medical devices, and IVDs with those frameworks used by the EU Medical Device Regulation (EU MDR) and EU In Vitro Diagnostic Regulation (EU IVDR).

However, the European Commission published a proposal in December 2025 to simplify the EU MDR, including revisions to product classification, so divergence may yet reappear. We note, though, that under the Draft Amendment, software as a medical device (SaMD) would generally still be classified as Class I in Great Britain (as opposed to Class IIa under the EU MDR currently), but the European Commission proposal has suggested down-classifying some SaMD to Class I under the EU MDR as well.

4. Other Elements

Safety and performance requirements: The Draft Amendment updates the “essential requirements” for devices to be consistent with the general safety and performance requirements under the EU MDR and EU IVDR (as applicable).

Technical documentation: Technical documentation must be kept in English, readily searchable, up to date, and available for inspection by the MHRA. Retention periods are extended to the later of the lifetime of the device plus 10 years, or plus 15 years for implantable devices.

Misleading or unsubstantiated claims: The Draft Amendment prohibits misleading or unsupported claims about a device’s intended purpose, safety, or performance across instructions for use, labelling, packaging, and promotional or sales materials. This prohibition is broadly consistent with the corresponding prohibition under the EU MDR.

Electronic instructions for use: The Draft Amendment broadens when electronic instructions for use may replace paper instructions for specified devices, subject to a documented risk assessment and safeguards on access, updates, website security, and paper-copy availability.

Equivalence claims: The Draft Amendment introduces an equivalence regime requiring a manufacturer relying on clinical data from another device in the clinical evaluation of its own device to demonstrate that it is equivalent to the other product by reference to technical, biological, and clinical characteristics.

Pre-determined change control plans: The Draft Amendment introduces a “pre-determined change control plan” (PCCP) for SaMD. A manufacturer can set out potential prospective changes it envisages making to the SaMD in a PCCP. Then, provided such changes are within the scope of the PCCP, the manufacturer may go ahead and implement the changes in due course without triggering a full re-certification process of the SaMD by a UK approved body. The PCCP must receive approval from a UK approved body and included in the SaMD’s technical documentation before the proposed changes may be implemented.

Looking Ahead

The MHRA’s survey seeking views on the impact of the Draft Amendment is open until 19 June 2026. The Draft Amendment is expected to be adopted in December 2026 and come into force in June 2027, subject to review and approval by the UK Parliament. The international reliance pathway is anticipated to take effect in 2028.

Medical device manufacturers, UK responsible persons, and other economic operators placing devices on the Great Britain market should assess how the proposed changes may affect existing and pipeline products, including product classification, traceability, safety and performance requirements, technical documentation, labelling, and claims. Those compliant with the EU MDR may be ahead in preparation; however, recent European Commission proposals to simplify aspects of the EU MDR and IVDR, if passed, may result in continued divergence between the UK and EU regulatory landscape for medical devices.