United Kingdom to implement continuous monitoring for AI medical devices

The United Kingdom government has announced it will accept all 44 recommendations from the National Commission into the Regulation of AI in Healthcare. This decision marks a shift toward continuous monitoring of AI-enabled medical devices rather than relying solely on one-time pre-approval safety checks.

Lawrence Tallon, Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA), noted that the move addresses the complexity of “non-deterministic algorithms” that evolve and adapt during clinical use. To support this, the MHRA is launching the third phase of its “AI Airlock” regulatory sandbox, which focuses on post-market surveillance and monitoring devices throughout their entire lifecycle.

The government intends to publish a preliminary implementation plan by the end of this year, with a full plan expected by spring 2027. This framework will establish delivery targets and timelines for implementation across the National Health Service (NHS).