The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation on proposals to introduce indefinite recognition of CE-marked medical devices in Great Britain (GB). The initiative is intended to safeguard patient access and ensure the continued supply of safe and effective medical technologies.
Approximately 90% of medical devices currently used in GB carry CE marking. The proposed indefinite recognition framework would provide longer-term regulatory certainty and help maintain continuity of supply across the health system.
This consultation builds on transitional arrangements introduced in 2023 to recognise CE-marked devices and forms part of the MHRA’s broader programme of medical device regulatory reform. The wider reform agenda aims to establish a system that is risk-proportionate, innovation-friendly and patient-centred.
Key Proposals Under Consultation
- The MHRA is seeking stakeholder views on three principal measures:
- Extension of transitional arrangements for MDD-certified devices
- Extend current 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), in order to minimise the risk of supply disruption.
- Indefinite recognition of EU MDR and IVDR devices
- Introduce indefinite recognition of devices compliant with the EU MDR and EU IVDR frameworks to reduce the risk of interruptions to device availability for patients in GB.
- International reliance route for certain higher-risk devices
- Establish a reliance pathway for a limited number of CE-marked devices that would fall into a higher risk classification under GB rules, ensuring appropriate regulatory oversight while maintaining market access.
This consultation closes at 11:59pm on 10 April 2026
To take part in the consultation, please use the following link
