By World Pharma AI Editorial
1 sourceThe UK government said on 6 October 2026 that it will accept all 44 recommendations of the National Commission into the Regulation of AI in Healthcare, published on 10 September. The MHRA opened applications the same day for the third phase of AI Airlock, its regulatory sandbox for AI-enabled medical devices 1.
What the government committed to
The Commission concluded that regulation must move to a more proportionate, lifecycle-based framework. AI-enabled medical devices should be assessed and monitored throughout their working life instead of over-relying on one-time assessments 1. The MHRA established the Commission in September 2025 as an independent, non-statutory advisory body. Its year-long, UK-wide evidence gathering involved more than 12,000 people. The MHRA describes this as the largest engagement of its kind on the regulation of healthcare technology 1.
The response sets out several first steps:
- The MHRA will issue draft guidance by December 2026 on managing changes to AI-enabled medical devices as they adapt and improve over time 1.
- The MHRA will consult next year on how to qualify and classify AI-enabled devices, which was the Commission's first recommendation 1.
- The government will explore staged authorisation pathways, allowing promising AI tools to be used in the NHS earlier under close supervision while further real-world evidence is gathered 1.
- A full implementation roadmap covering timelines and responsibilities for all 44 recommendations will be published by Spring 2027 1.
The government also committed to strengthen patient engagement in decision-making, improve access to redress where care falls below expectations, and keep patients informed about when AI is used in their care 1. A newly established Programme Board will oversee work across government, the MHRA, NHS partners and the devolved authorities on nine priority areas 1.
AI Airlock has secured three years of additional government funding following a pilot and a Phase 2 programme. Phase 3 will focus on post-market surveillance and lifecycle regulation. It will work with real products to test how devices can be monitored and managed after deployment, and its findings will inform future MHRA guidance and policy 1. Sir Andrew Goddard, chairman of the AI Airlock Governance Board, said the next three years would have "a focus on understanding how AI products can be monitored effectively once they are in use." 1
What it means for the market
The main group affected is developers of AI as a Medical Device. The regulator is moving away from a single point-in-time assessment and towards continuous, real-world monitoring after deployment 1. For companies whose products adapt and improve over time, the December 2026 draft guidance on device changes is the first concrete text due. The consultation next year will cover how AI-enabled devices are qualified and classified 1.
The staged authorisation pathways matter to NHS buyers and to investors. They would allow supervised NHS use while further real-world evidence is gathered, but the government has committed only to exploring them 1. Steve Bates, Executive Chair of the Office for Life Sciences, said: "By providing innovators, investors and the health system with greater clarity and confidence, these reforms will help accelerate the safe development, scaling and adoption of AI technologies." 1 Steve Lee, Executive Director, Regulation at ABHI, said: "Building on, and aligning with, international best practice will be key." 1
Several things are still unknown. The release does not give the amount of the Airlock funding, the number of companies Phase 3 will take or the eligibility criteria in detail. It does not give the timetable for most of the 44 recommendations, which waits on the roadmap 1.
Scotland has not yet set out its response. Scottish Health Secretary Angela Constance said Scotland will publish its own response later, and that it already has interim guidance on AI in health and social care, with a policy framework due to publish later this year 1.
Health Innovation Minister James Frith said: "This will be a continually-evolving process as the technology itself develops" 1.
Applications for AI Airlock Phase 3 close in November 2026, when the first wave of innovators will be selected. A webinar for prospective applicants takes place on 22 October 2026 at 10:00 1.
References
- Government backs recommendations of NHS doctors-led AI Commission (opens in a new tab) — Medicines and Healthcare products Regulatory Agency
This briefing summarises publicly available research and reporting for information only. It is not medical, investment or legal advice. Follow the references to the primary sources.
