UK regulator backs ongoing AI device oversight

The agency adopted every recommendation put forward by the independent panel, which includes NHS physicians.

The commission’s primary finding emphasized that AI-driven medical tools require ongoing oversight throughout their operational lifespan, instead of relying solely on initial evaluations. This aligns with similar considerations by agencies like the Food and Drug Administration, which are exploring continuous postmarket surveillance as a regulatory strategy.

The commission advised that once AI-powered products are in use, they should undergo constant monitoring, as single pre-market tests will not suffice. The report stressed that trust must be established, given public excitement about AI’s benefits and concerns over its potential dangers.

The MHRA intends to release draft guidelines by December outlining a new framework for managing updates to AI-enabled devices as they evolve. It will also begin consultations in the new year regarding criteria and classifications for AI-powered medical products. A full implementation plan covering all 44 recommendations is scheduled for publication by spring 2027.

MHRA Chief Executive Lawrence Tallon said in a statement, “This is about making sure patients can benefit from safe, trusted AI more quickly, while never losing sight of the safeguards that maintain public confidence.” The MHRA also opened applications for its regulatory sandbox for AI-enabled devices, AI Airlock, with the first selections taking place in November.