UK regulator backs continuous oversight for AI medical devices

The U.K.’s Medicines and Healthcare Products Regulatory Agency has adopted all 44 recommendations from the National Commission into the Regulation of AI in Healthcare, an independent group led by National Health Service physicians. The recommendations emphasize that AI-enabled medical devices should be monitored throughout their working life rather than cleared through one-time assessments.

The commission warned that existing regulatory approaches were built for static products that are easier to assess at a single point in time. AI-enabled devices can change quickly, and their performance may vary by setting, workflow, users and surrounding organizations, making continuous oversight a central part of maintaining safety and trust.

The MHRA plans to issue draft guidance by December on managing changes to AI-enabled devices as they adapt over time. It will also consult at the start of the year on how to qualify and classify AI-enabled devices and publish a full implementation roadmap addressing the 44 recommendations by spring 2027.

The regulator also opened applications for AI Airlock, its regulatory sandbox for AI-enabled devices. The latest cohort will focus on post-market surveillance and lifecycle regulation, with first selections taking place in November.