MHRA Consultation on Indefinite Recognition of CE-Marked Medical Devices

The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has initiated a public consultation regarding proposals for the indefinite recognition of CE-marked medical devices. This move aims to protect patient access and ensure the consistent supply of safe and effective medical technologies, as approximately 90% of devices currently used in Great Britain are CE marked. Key proposals include extending transitional arrangements for EU Medical Device Directive (MDD) certified devices, indefinite recognition of EU Medical Device Regulation (EU MDR) and EU In Vitro Diagnostic Regulation (EU IVDR) compliant devices, and introducing an international reliance route for certain higher-risk CE-marked devices. The consultation is open until April 10, 2026.

This consultation is critical for medical device manufacturers, Approved Bodies, UK Responsible Persons, healthcare professionals, and patient groups. The proposals are designed to provide long-term certainty for the med tech industry, reduce friction and costs, and ensure continued patient access to essential medical devices. Companies should review the proposals and submit feedback by the April 10, 2026 deadline. The MHRA intends to reposition UKCA as a specialist route for innovative, first-in-market products, including AI as a medical device, and will continue to strengthen post-market surveillance and information sharing with EU partners.