UK MHRA Opens Consultation on Proposals for Indefinite Recognition of CE Marked Medical Devices

By Karen Hill 

Background

The UK medical device regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has announced the launch of a targeted consultation on the indefinite recognition of CE-marked devices. This follows the outcome of the MHRA’s public consultation on proposed amendments to the UK’s Medical Devices Regulations  2002 (MDR 2002), published in July 2025. 

Overview

The consultation applies to medical devices and IVDs for Great Britain (GB) (England, Scotland, and Wales). Views are sought from anyone who will be impacted by the proposals, including medical device manufacturers and distributors, trade associations, regulatory experts, approved bodies, healthcare professionals, including clinicians and those involved in procurement of medical devices, devolved administrations and patient representative organizations. There are three proposals for stakeholders to comment on.

The three proposals

The consultation has three proposals:

1. Extend the current GB transitional arrangements for devices that comply with the EU Medical Devices Directive (MDD) to align with the transitional timelines published by the EU for transition to the EU Medical Devices Regulation (EU MDR).

2. Indefinitely recognize devices that comply with the EU MDR and EU in vitro Diagnostic Medical Devices Regulation (EU IVDR), and 

3. Introduce an international reliance route for devices that comply with the EU MDR and EU IVDR where the device classification is higher under the MDR 2002.

Current transitional arrangements

Under the existing transitional arrangements, there will be a period of approximately six months where devices still accepted in the EU and Northern Ireland (under the MDD) will not be eligible to access the GB market. In addition, the current transitional arrangements will end on June 30, 2030, after which, CE-marked devices will no longer be accepted in GB and UKCA marking will be required. Additionally, devices approved in the EU would need to comply with the MDR 2002 and undergo conformity assessment by a UK-approved body, if applicable, to access the GB market.

MHRA consultation procedure and timeline

The consultation comprises three Yes/No questions, one for each proposal, with the opportunity to provide further, optional comments. The consultation is now open and closes at 11:59 p.m. on April 10, 2026. Responses should be submitted online or emailed to futuredevicesregulations@mhra.gov.uk.

Concluding remarks

These are welcome developments in enabling a continued supply of medical devices for patients in GB (MHRA states that 90% of the compliance of devices is based on compliance to the EU legislation), whilst also contributing to global harmonization and regulatory reliance and reduced burden for medical device manufacturers.

If you would like your opinions to be considered, submit your responses before the April deadline.