Ministers back independent Commission's blueprint in full, while the MHRA's AI Airlock opens its next phase,
The government has today, 6 October 2026, 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 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.
A new approach to regulating AI in healthcare
The Commission concluded that the current regulatory approach must evolve for AI technologies by designing a more proportionate, lifecycle-based framework.
Today’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.
One of the Commission’s central conclusions was that AI-enabled medical devices should be assessed and monitored throughout their working life to better understand true performance, instead of over-relying on one-time assessments. AI Airlock Phase 3 puts this principle into practice immediately, working with developers, regulators and healthcare partners to test how AI devices can be safely monitored and managed for post-market surveillance after they are deployed, generating insights, evidence and solutions that will directly inform future MHRA guidance and policy. Applications are now open for developers of eligible AI-enabled medical devices, with a webinar for prospective applicants taking place on 22 October.
Among the first steps set out in today’s response, the MHRA is also committed to issue draft guidance by December 2026 on a new approach to managing changes to AI-enabled medical devices as they adapt and improve over time, moving towards a regulatory system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.
Excerpt from the official page. The original is authoritative. Continue reading at UK MHRA ↗