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The UK Government has confirmed it will accept all 44 recommendations made by the National Commission into the Regulation of AI in Healthcare, published 10 September, and has set out how they will be delivered across the UK. Alongside the response, the Medicines and Healthcare products Regulatory Agency (MHRA) is opening the call for applications for the third phase of AI Airlock, its regulatory sandbox for AI-enabled medical devices, with testing themes directly informed by the Commission’s recommendations.
The Commission concluded that the current regulatory approach must evolve for AI technologies by designing a more proportionate, lifecycle-based framework.
The Government's response commits the UK to developing a world-leading agile approach to AI device regulation that supports innovation while maintaining patient safety and public trust. The reforms aim to ensure patients can benefit from safe, effective and trusted AI more quickly, while maintaining robust safeguards as technologies evolve.
Among the first steps set out in today’s response, the MHRA is also committed to issue draft guidance by December 2026 on a new approach to managing changes to AI-enabled medical devices as they adapt and improve over time, moving towards a regulatory system that is designed to maintain safety while supporting timely access to innovative devices. The MHRA will also begin next year by consulting on how to qualify and classify AI-enabled devices, the first recommendation of the National Commission.
Other commitments include exploring new staged authorisation pathways, allowing promising AI tools to be used in the NHS earlier under close supervision while further real-world evidence is gathered. A full implementation roadmap, setting out timelines and responsibilities across all 44 recommendations, will be published by Spring 2027, with regular progress updates to follow.
Source: MHRA, 6 October 2026
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