The UK government plans to accept qualifying CE-marked medical devices indefinitely in Great Britain, removing time limits on their route to market without an additional British pre-market review.
The Medicines and Healthcare products Regulatory Agency (MHRA) announced the proposal on Oct. 21. It covers CE-marked devices compliant with the EU Medical Devices Regulation (EU MDR) and EU In Vitro Diagnostic Medical Devices Regulation (EU IVDR). The policy would apply in England, Scotland and Wales; Northern Ireland has separate medical-device rules. Legislation and parliamentary approval are still required.
CE marks appear on more than 90% of devices registered for use in Great Britain, the MHRA said. The government expects continued recognition to reduce duplicate regulatory work for manufacturers and lower the risk of supply interruptions for patients, but gave no estimate of potential savings. The domestic UKCA marking route would remain available.
The consultation received 1,056 responses. Of those, 608 supported indefinite recognition for all devices in scope, 335 opposed it, 102 favored a narrower option for devices classified at the same or a lower risk level in Great Britain, and 11 expressed no opinion. Seven of the nine patient groups that responded opposed broad recognition. The government response records concerns about safety oversight and accountability without an additional British review.
Devices certified under the older EU Medical Devices Directive are outside the indefinite plan. The government intends to extend their recognition to the end of the EU transition period, currently Dec. 31, 2028. Qualifying devices placed on the EU or Great Britain market before that period ends may remain on the Great Britain market. Current British guidance sets the earlier of certificate expiry or June 30, 2028, as the deadline for eligible devices under the directive, subject to transition conditions. The current time limits reflect earlier post-EU-exit arrangements.
Manufacturers would still need to register covered devices with the MHRA and meet British post-market surveillance requirements. Companies based outside the UK would also need a UK responsible person. The agency aims to have the legal changes approved before June 30, 2028, when the earliest relevant existing transition expires. Current MHRA guidance continues to list time-limited recognition deadlines while the proposal awaits approval.
