MHRA consults on indefinite recognition of CE-marked MedTech

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a consultation on proposals for indefinite recognition of CE-marked medical devices in Great Britain.

The consultation is aimed at protecting patient access and ensuring the supply of safe and effective medical technologies.

Around 90% of medical devices currently used in Great Britain are CE-marked, and the MHRA says that indefinite recognition would ensure consistent long-term supply to support the health system.

The consultation seeks feedback on proposals to extend arrangements put in place in 2023 to recognise CE-marked devices, and forms part of the MHRA’s wider regulatory reform of medical devices.

Lawrence Tallon, chief executive at the MHRA, said: “The number one request that the MedTech industry made of us was to provide long-term certainty over CE recognition.

“It is in the best of interests of British patients to ensure continued access to the latest medical devices approved in Europe.

“It is also in the best interests of the MedTech sector to reduce friction and costs of doing business.

“We have listened carefully and acted on this clear and consistent feedback, which is why we are now pleased to consult on these proposals for indefinite recognition of CE marked medical devices.”

He added that MHRA will re-position UK Conformity Assessed (UKCA) as a specialist route for first-in-market innovative products, including AI as a medical device, informed by the findings of the National Commission into the Regulation of AI in Healthcare which will report this summer.

The proposals include extending current transitional arrangements for devices certified under the EU Medical Device Directive, indefinite recognition of EU MDR and EU IVDR-compliant devices, and introduction of an international reliance route for CE-marked devices that would fall into a higher risk class in Great Britain. 

They would be delivered alongside a domestic route to market focused on support for innovation, helping the UK achieve its goal of becoming a leading country for MedTech access by 2030, and aligned with the Life Sciences Sector Plan.

Alongside these measures, the MHRA will continue to strengthen post-market surveillance and work to improve information sharing with EU partners.

The consultation opened on 16 February 2026 and will run until 10 April 2026, with feedback encouraged from medical device manufacturers, approved bodies, UK Responsible Persons, healthcare professionals, patient groups, and the public.

Meanwhile in August 2025, the MHRA set out plans enabling manufacturers to supply innovative medical devices for unmet clinical needs to the NHS before obtaining full regulatory approval.