Jan 2026 “In All Other News”: EMDN, EUDAMED, WET Updates, and more
2 February 2026
Feb “In All Other News”: MHRA Guidance Updates, New swissdamed Functionality, & More
2 March 2026Background
In November 2024, the MHRA opened a consultation on a new International Reliance framework. In addition to the US and Australia, the MHRA proposed reliance against European CE Marking.
In July 2025, the MHRA advised, based on feedback from the consultation, it would explore possibly recognizing CE Marking indefinitely, instead of including it in the International Reliance framework.
New Consultation
The MHRA has opened a new consultation on CE Marking: HERE
The feedback period is open from Monday 16 February 2026 to Friday 10 April 2026.
It covers the following three topics:
Extending the MDD Transition Period
This is intended for legacy devices that comply with the EU MDD. The MHRA proposes to align its legacy device transition period to match the EU for transition for MDD to MDR, i.e., to close the six-month gap for low-to-mid-risk devices.
The EU allows those compliant legacy devices on the market until 31 December 2028, while the UK cutoff is 30 June 2028.
Indefinitely Recognizing MDR/IVDR CE Marked Devices
The MHRA proposes indefinite recognition of devices that comply with the EU MDR and IVDR.
The consultation asks for your feedback, regarding whether this should be:
- For all devices, or
- Only for those which are classified as the same, or a lower risk category under the UK MDR 2002 as they are in the relevant EU device regulations.
Devices under indefinite recognition would be accepted at “face value”, i.e., no additional verification needed by a UK Approved Body. However, devices must still continue to be registered with the MHRA, and manufacturers located outside of the UK, must continue to appoint a UK Responsible Person (UKRP). Further, the MHRA may introduce additional requirements in the future, such as requiring the manufacturer (or its UKRP) to provide information to the MHRA, upon request.
Requiring International Reliance for Some CE Marked Devices
For those that agree indefinite recognition should not be extended to devices classed higher in the UK than in the EU, the MHRA would like your feedback on an international reliance route.
