Prime Highlights
- The MHRA proposes long-term recognition of CE-marked medical devicesin Great Britain to protect patient access and ensure a steady supply.
- About 90 percent of devices in usecarry CE certification, and indefinite recognition would reduce disruption and regulatory costs for manufacturers.
Key Facts
- The consultation covers extending arrangements for devices under the EU Medical Device Directive, EU MDR, and EU IVDR, and creating an international reliance route for higher-risk CE devices.
- MHRA plans to reposition UKCA markingas a specialist pathway for first-in-market innovations, including AI-based medical devices.
Background
The Medicines and Healthcare products Regulatory Agency has opened a public consultation on plans to continue recognising medical devices approved in the European Union for use in Great Britain on a long-term basis.
The proposal seeks to extend transitional arrangements introduced in 2023 and allow CE-marked medical devices to remain available beyond 2030. The regulator said the move would protect patient access and maintain a steady supply of safe and effective medical technologies across the health system.
According to the agency, about 90 percent of medical devices currently used in Great Britain carry CE certification. Officials believe indefinite recognition would reduce disruption for hospitals, lower regulatory costs for manufacturers and provide greater certainty for the medtech sector.
The consultation focuses on three key measures. These include extending arrangements for devices certified under the EU Medical Device Directive, continuing recognition of products compliant with EU MDR and EU IVDR rules, and creating an international reliance route for higher-risk CE-marked devices.
MHRA chief executive Lawrence Tallon said industry stakeholders had asked for long-term clarity on CE recognition. He added that the approach would support patient access while reducing business friction. The regulator also plans to reposition the UKCA marking as a specialist pathway for first-in-market innovations, particularly artificial intelligence-based medical devices.
Alongside the consultation, the MHRA has expanded its work on emerging technologies. It recently introduced paid regulatory advice meetings for medical device manufacturers and launched a call for evidence on the future regulation of AI in healthcare. Findings will inform a national commission reviewing rules for AI as a medical device.
The agency has also issued new public guidance on digital mental health tools, including information on safety standards and how to report concerns through the Yellow Card scheme.
The consultation invites responses from industry, clinicians and the public as the UK reshapes its medical device regulatory framework.
