UK medical devices reform: MHRA consults on indefinite CE mark acceptance

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has launched a significant consultation on proposed reforms to the way CE‑marked medical devices are recognised in Great Britain, including indefinite recognition of EU MDR/IVDR compliant devices. 

The consultation forms part of the UK’s wider programme to refine its post‑Brexit regulatory system while supporting continued access to safe and innovative medical technology. The MHRA is seeking feedback from a broad church of participants — including manufacturers, distributors, clinical professionals, procurement organisations, trade bodies, regulatory experts and patient groups.

This latest consultation follows the Government’s July 2025 response to a consultation on medical device reforms, UKCA marking and IVD requirements and future reliance routes to market, including plans for a new international reliance framework. For background, please see our previous post discussing that response.

The MHRA is now consulting on three principal proposals:

1. Potential extension of the current transitional provisions

The first proposal concerns a possible extension of the transitional arrangements for devices certified under the former Medical Devices Directive (MDD). These arrangements are currently due to expire on 30 June 2028. The MHRA is considering aligning Great Britain’s transition timelines with those applicable under the EU’s Medical Devices Regulation 2017/745 (EU MDR). If adopted, this would allow MDD‑certified devices—many of which are actively transitioning to the EU MDR—to remain on the Great Britain market until 31 December 2028, rather than the existing 30 June 2028 deadline. The consultation also clarifies that, should the EU extend its own transition timelines again, those extensions would likewise be reflected in Great Britain.

2. Indefinite recognition of EU MDR/IVDR‑compliant devices

The second proposal is the indefinite acceptance in Great Britain of medical devices that comply with the EU MDR and the In Vitro Diagnostic Medical Devices Regulation 2017/746 (EU IVDR). Under the current rules, CE recognition ends on 30 June 2030, after which only UKCA‑marked devices would be eligible for placement on the Great Britain market.

The MHRA is considering amending this and looking for opinions on whether indefinite recognition should apply to:

• all EU MDR/IVDR‑compliant devices, meaning EU classification rules would be followed and applied in Great Britain; or
• only those devices that fall within the same or a lower risk class under the UK MDR 2002, which would mean that UK classification rules would take precedence where a device would be categorised as higher risk domestically.

Devices entering Great Britain through this route would still need to be registered with the MHRA and comply with UK post‑market surveillance obligations but would not require separate assessment by a UK‑approved body. Ongoing oversight would continue to be carried out by the relevant EU notified body.

3. Introduction of a new international reliance pathway

The third issue that the MHRA is seeking views on is a proposed international reliance route for devices that comply with the EU MDR or EU IVDR but fall into a higher risk category under the UK MDR 2002. This new EU-based reliance pathway is intended to streamline the regulatory process, reduce regulatory duplication and enable smoother market access. The intention is that it would operate in parallel with the anticipated route to marked for medical devices with existing approvals from Australia, Canada and the USA, which the Government committed to developing in its July 2025 consultation response.

Under the latest proposal, manufacturers could continue using the existing transitional arrangements until 30 December 2030, after which they may either transition to UKCA conformity assessment or apply via this new EU‑based reliance route. As outlined in Annex B to the consultation, eligible manufacturers would receive an international reliance certificate, allowing registration of their device with the MHRA and access to the Great Britain market. The certificate would not constitute a UKCA mark and would be valid only for the duration of the corresponding EU MDR/IVDR certification.

Notably, the MHRA is proposing that the route would not be available for products and devices that are self‑declared under the EU system but would be placed in a higher risk class category in Great Britain — for example, CE‑marked Class I devices that would fall into the higher Class IIa category in Great Britain, would instead require full UKCA conformity assessment.

The MHRA’s proposals aim to support long‑term supply certainty, reduce unnecessary regulatory burden, and promote a more proportionate, risk‑based oversight regime for medical devices in Great Britain, while remaining consistent with recognised international standards.

Interested parties have until 10 April 2026 to respond via the MHRA’s online portal, email, or postal submission.

This article was written by Katie Carter from our Health and Life Sciences team.