UK will monitor AI-based medical devices

Medical devices based on artificial intelligence (AI) will need constant monitoring even after they are approved for use, rather than a single safety check prior to approval, the head of the UK medicines regulator, Lawrence Tallon, said on Tuesday.

The UK government will accept all 44 recommendations from a report into the approval process for these AI tools, it said.

The government commits to publishing a full implementation plan by spring 2027 (in the Northern Hemisphere), with a draft version expected later this year.

The plan will set delivery targets and deadlines for implementing each change across the National Health Service (NHS).

The UK is the first country to develop comprehensive rules for this emerging technology.

Tallon, chief executive of the Medicines and Healthcare products Regulatory Agency (MHRA), told Reuters that many countries are now reaching out to the UK to learn from its approach.

“We are entering a much more sophisticated and complex era of AI as a medical device, where we have non-predictable algorithms,” he said, referring to AI systems that evolve and adapt as doctors use them.

The MHRA will also begin accepting applications for the third phase of its “AI Airlock” program, focusing on post-market surveillance and monitoring of devices throughout their lifecycle, once they are used in clinical practice.