UK's MHRA Consults on Recognising CE-Marked Medical Devices Indefinitely

Britain's medical device regulator has proposed accepting devices that carry the European Union's CE mark on the Great Britain market indefinitely, a step it said answers the medtech industry's main request for long-term certainty.

The Medicines and Healthcare products Regulatory Agency launched a consultation on February 16 that runs until April 10. Around 90% of medical devices currently used in Great Britain are CE marked, the agency said, and the proposals would extend measures put in place in 2023 that recognise CE-marked devices on the GB market up to 2030.

Three proposals

The consultation seeks views on extending transitional arrangements for devices certified under the older EU Medical Device Directive, aligning GB timelines with the EU's own transition to the Medical Device Regulation; on indefinitely recognising devices that comply with the EU MDR and the In Vitro Diagnostic Medical Devices Regulation; and on an international reliance route for a small proportion of CE-marked devices that would fall into a higher risk class under GB rules, according to the MHRA.

The agency is also asking whether recognition should apply to all devices or only to those classified at the same or a lower risk level under the UK's Medical Devices Regulations 2002 than under EU rules, RAPS reported. The consultation covers general medical devices, active implantable devices and in vitro diagnostics in England, Scotland and Wales.

Most manufacturers delayed moving to the UK's own UKCA mark while the agency developed its international reliance scheme, the MHRA said in the consultation, according to RAPS. Devices recognised under the proposal "would continue to be placed on the GB market without additional checks by an approved body," the agency said, as quoted by RAPS. That would mean no ongoing UK approved body oversight once the devices are on the market; instead they would continue to be monitored by an EU notified body under EU rules, RAPS reported.

Industry certainty and a new role for UKCA

"The number one request that the med tech industry made of us was to provide long term certainty over CE recognition," MHRA Chief Executive Lawrence Tallon said. "It is also in the best interests of the med tech sector to reduce friction and costs of doing business."

Tallon said the agency would "re-position UKCA as a specialist route for first-in-market innovative products, including AI as a medical device," informed by the findings of a National Commission into the Regulation of AI in Healthcare due to report in the summer.

The MHRA said it would continue to strengthen post-market surveillance and work to improve information sharing with EU partners alongside the measures. The proposals follow a July 2025 government response to an earlier consultation on future routes to market, in which a recurring request was to extend CE recognition indefinitely, RAPS reported.

The agency said the plans align with the government's Life Sciences Sector Plan and 10-Year Health Plan and support its goal of making the UK a leading country for medtech access by 2030. It invited responses from manufacturers, approved bodies, UK responsible persons, health care professionals, patient groups and the public.