UK medicines regulator the MHRA has opened a consultation on indefinite CE mark recognition for medical devices in Great Britain.
Around 90 per cent of medical devices currently used in Great Britain are CE marked, a certification showing they meet EU safety standards.
The proposals aim to support long-term supply and sit within the MHRA’s wider programme of regulatory reform.
The consultation seeks views on three proposals: extending current transitional arrangements for devices certified under the EU Medical Device Directive and aligning GB timelines with the EU’s move to the EU Medical Device Regulation; indefinite recognition of devices compliant with EU MDR and EU IVDR, which covers in vitro diagnostic devices such as lab tests; and introducing an international reliance route for a small proportion of CE-marked devices that would fall into a higher-risk class under GB rules.
Lawrence Tallon, chief executive at the MHRA, said: “The number one request that the med tech 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 of interests of the med tech 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.
“In addition, we will re-position UKCA as a specialist route for first-in-market innovative products, including AI as a medical device. This will be informed by the findings of the National Commission into the Regulation of AI in Healthcare which will report this summer.”
The proposals would be delivered alongside a domestic route to market focused on supporting innovation, with the government aiming for the UK to become a leading country for medtech access by 2030 in line with its Life Sciences Sector Plan and 10-Year Health Plan.
The MHRA said the proposals align with wider government policy for other manufactured goods sectors where continued recognition of CE-marked goods has already been agreed.
Alongside these measures, the agency said it will continue to strengthen post-market surveillance and work to improve information sharing with EU partners.
The MHRA is encouraging feedback from medical device manufacturers, approved bodies, UK responsible persons, healthcare professionals, patient groups and the public.
