UK says it will monitor AI-based medical devices continually

UK Sets Continuous Monitoring Rules for AI-Based Medical Devices in NHS

New Regulatory Approach for AI Medical Devices

By Bhanvi Satija

Continuous Monitoring Requirement

LONDON, Oct 6 (Reuters) - AI-based medical devices will need constant monitoring even after they're approved for use, rather than a single pre-approval safety check, the head of the UK's medicines regulator said on Tuesday.

Government Response and Implementation

The UK government will accept all 44 recommendations from a report on how such AI tools are approved, it said.

Implementation Timeline and Targets

• The government commits to publishing a full implementation plan by spring 2027, with a draft plan expected by the end of the year

Delivery Across the NHS

• The plan will spell out delivery targets and timelines for putting each change into place across the NHS

Global Leadership and Collaboration

• Britain is the first country to develop comprehensive rules for this emerging technology

• Lawrence Tallon, Medicines and Healthcare products Regulatory Agency Chief Executive, told Reuters many nations are now approaching the UK to learn from its approach

AI Technology and Regulatory Programs

• "We're moving into a much more sophisticated and complex era of AI as a medical device where we have non-deterministic algorithms," he said, referring to AI systems that evolve and adapt while doctors are using them

• The MHRA will also start accepting applications for the third phase of its AI Airlock program, focusing on post-market surveillance and lifecycle monitoring after devices enter clinical practice

(Reporting by Bhanvi Satija, Editing by Rosalba O'Brien)