Confirmation of Indefinite Recognition of CE Marked Medical Devices in Great Britain

By Karen Hill

Overview

Following the public consultation earlier this year on the indefinite recognition of CE marked medical devices in Great Britain (GB), the U.K. medical device regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has confirmed that it will continue to accept CE marked devices on a long-term basis.

Consultation outcome

After receiving more than 1,000 responses from a wide range of stakeholders, including medical device and IVD manufacturers, U.K. Responsible Persons (UKRPs), Approved Bodies, notified bodies, healthcare professionals, patient groups and other interested parties, the MHRA has confirmed that medical devices already approved for the European market under the CE marking system will continue to be accepted in GB without requiring a separate U.K.-specific approval process. 

Furthermore, the MHRA has confirmed that while CE-marked products will continue to be accepted, the UKCA marking route will remain available as the domestic approval pathway for devices marketed in GB.

Extended transitional timelines

In addition, as a result of the feedback received on Proposal 1 of the consultation, the MHRA has confirmed that it intends to align the timelines for recognizing devices approved under the EU Medical Devices Directive (MDD) with the EU timelines for devices to transition to the EU Medical Device Regulation (MDR). 

This means that instead of the current end date of June 30, 2028, EU MDD certified devices will be accepted in GB until Dec. 31, 2028 (end of the EU transition period), thereby preventing supply disruption for the six months between June 30 and Dec. 31, 2028, while also minimizing unnecessary administrative burden for economic operators.

Rejected proposals

Proposals 2b and 3, which together introduced a separate reliance route based on divergent classification, were rejected to prevent unnecessary regulatory complexity.

MHRA governance

The MHRA will continue to oversee all devices on the U.K. market, regardless of their route to market, and manufacturers of CE marked devices placed on the GB market must continue to comply with current requirements, including the appointment of a UKRP (if based outside the U.K.), MHRA registration and post-market surveillance (PMS) obligations. 

Technical documentation and certificates of conformity must also be prepared and made available in English.

Implementation timelines

Subject to parliamentary approval, these legislative changes will be made prior to June 30, 2028.

Concluding remarks

These are welcome developments that support the continued supply of medical devices for patients in GB while also reducing the regulatory burden on medical device manufacturers.