The UK Government is running a targeted consultation on the possible indefinite recognition of CE‑marked medical devices on the Great Britain market. This initiative is part of a wider reform of the UK’s medical device regulatory framework. According to the Medicines and Healthcare products Regulatory Agency (MHRA), around 90% of medical devices in Great Britain are CE-marked.
The consultation has opened on 16 February 2026 and will run until 10 April 2026. The Agency is looking to receive feedback from all parties impacted by this extension, including manufacturers, distributors, associations, approved bodies, healthcare professionals, and similar.
Key proposals under consultation: extension, indefinite recognition, and international reliance
The consultation seeks views on three main proposals:
- Extending current transitional provisions for CE-marked devices according to the EU legacy requirements, in order to minimise the risk of supply disruption.
- Indefinite recognition of CE-marked devices, to reduce the risk of interruption to the supply.
- Introducing an international reliance route for a small proportion of CE-marked devices (only when they fall into a higher risk class under UK regulations).
Currently, CE-marked medical devices and IVDs are accepted in Great Britain only until 2030, depending on their class and regulatory status. With the current consultation, CE-marked medical devices and IVDs might be accepted in Great Britain for an indefinite period of time.
Questions on this topic? Contact us here or at mdlaw@obelis.net.
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