CE marking in the UK: MHRA consults on indefinite recognition of EU-certified devices

Posted on 07.04.2026

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation on the future recognition of CE-marked medical devices and in vitro diagnostic devices in Great Britain, setting out options for the UK’s long-term regulatory approach.

The consultation seeks views on a number of proposals, including the potential for indefinite recognition of devices compliant with the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), alongside the introduction of an international reliance pathway for certain devices. It also considers the extension of transitional arrangements for devices certified under the EU Medical Device Directive (MDD), aligning timelines with the EU’s transition to the MDR.

These proposals will directly shape the conditions under which medical technologies can be placed on the Great Britain market in the coming years, with implications for regulatory alignment and market access.

Given the integrated nature of European and global medical technology supply chains, maintaining a clear and predictable regulatory framework will be important to support the availability of medical technologies and the effective functioning of both the EU and UK markets.

MedTech Europe encourages all impacted stakeholders to respond directly to the consultation by 10 April 2026.

For more information, please contact Clare Birmingham, Manager International Affairs.