London: 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.
The UK government will accept all 44 recommendations from a report on how such AI tools are approved, it said.
The government commits to publishing a full implementation plan by spring 2027, with a draft plan expected by the end of the year
The plan will spell out delivery targets and timelines for putting each change into place across the NHS
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
“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.
