Share your views: targeted consultation on the indefinite recognition of CE marked medical devices
The MHRA have launched a consultation on proposals for indefinite recognition of CE marked medical devices in Great Britain (GB). The consultation is open for seven weeks, from Monday 16 February to Friday 10 April 2026.
Around 90% of medical devices currently used in Great Britain are CE marked, and the proposals for indefinite recognition would ensure consistent long-term supply to support the health system.
The consultation seeks views on three key proposals:
- Extending current transitional arrangements for devices certified under the EU Medical Device Directive (MDD), aligning GB timelines with the EU’s transition to the EU Medical Device Regulation (EU MDR), to minimise the risk of supply disruption.
- Indefinite recognition of EU MDR and EU IVDR-compliant devices, to reduce the risk of interruption to the supply of medical devices for patients in GB.
- Introducing an international reliance route for a small proportion of CE-marked devices that would fall into a higher risk class under GB rules, to ensure appropriate oversight while maintaining access.
The MHRA is encouraging feedback from a wide range of stakeholders, including medical device manufacturers, Approved Bodies, UK Responsible Persons, healthcare professionals, patient groups and the public, to ensure the proposals deliver the best outcomes for patients and the health system.