Medical Devices Regulations – Targeted Consultation on the Indefinite Recognition of CE-Marked Devices

18th February 2026

Summary: The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a targeted consultation seeking stakeholder views on proposals to permanently recognise CE-marked medical devices (including IVDs) for the UK market, rather than requiring UKCA marking after existing transitional arrangements expire. The consultation focuses on options for which devices should be eligible (e.g., by risk class, type or regulatory history), how safety and performance data should be considered, and what additional UK-specific labelling or post-market surveillance might be needed. Feedback will help shape future regulations that aim to reduce administrative burden for manufacturers, maintain patient safety, and support access to innovative technologies.

Link: https://www.gov.uk/government/consultations/medical-devices-regulations-targeted-consultation-on-the-indefinite-recognition-of-ce-marked-devices

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