The Government has confirmed it will accept all 44 recommendations made by the National Commission into the Regulation of AI in Healthcare. 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.
In September 2026 the National Commission published its report Recommendations for a future regulatory framework, that has now been fully accepted, with ministers setting out how they will be delivered across the UK. The recommendations have also directly informed new testing themes for the next phase of the AI Airlock.
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Among the first steps set out in the response, the MHRA is also committed to issue draft guidance by December 2026 on a new approach to managing changes to AI-enabled medical devices as they adapt and improve over time, moving towards a regulatory system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.
In addition, the Government has committed to working with partners across the health system to strengthen patient engagement in decision-making, improve access to redress where standards of care fall below expectations, and ensure the benefits of AI are shared fairly across all communities, including underserved groups.
AI Airlock has secured three years of additional government funding. Phase 3 will focus specifically on post-market surveillance and lifecycle regulation, the themes at the heart of both the Commission’s recommendations and today’s response. Working with real products and technologies, the programme brings together innovators, regulators and healthcare partners to explore how AI-enabled medical devices can be monitored and managed safely throughout their working life, generating evidence and insights that will directly inform future MHRA guidance and policy. Eligible developers of AI-enabled medical devices can apply. The first wave of innovators will be selected in November 2026.
Lawrence Tallon, the MHRA’s Chief Executive, commented: “The independent National AI Commission, led by NHS doctors, has given us a clear and ambitious blueprint for how we make the UK the best place to get AI products to patients safely, quickly and in a way that maintains public trust. I am pleased that the Government is accepting its recommendations in full, whilst setting out a clear plan and oversight structure to deliver them. The MHRA’s AI Airlock is already opening its doors to more innovators who want to help us understand how these technologies can be implemented and monitored safely throughout their working life. 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 government’s full response, including its response to each individual recommendation, is available here.