The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has secured £3.6 million ($4.8 million) in multi year funding from the Department of Health and Social Care to scale up its pioneering AI Airlock programme the country’s first regulatory sandbox for Artificial Intelligence as a Medical Device (AIaMD) enabling longer term real world testing through 2029.
Glimpse:
Announced on April 8, 2026, the funding provides £1.2 million annually from 2026 to 2029. This will allow the AI Airlock initiative, launched as a pilot in 2024, to move beyond short term budget constraints and support broader evaluation of AI-powered diagnostic tools, change control plans, and expanded device indications. The programme is run jointly with the NHS AI Team and Team AB, with key findings scheduled for release in mid-2026.
The Medicines and Healthcare products Regulatory Agency (MHRA) has gained important financial support to strengthen regulation of artificial intelligence technologies in healthcare. The agency has received £3.6 million, roughly equivalent to $4.8 million, from the Department of Health and Social Care (DHSC) to expand its AI Airlock programme. This dedicated regulatory sandbox helps developers and regulators test innovative AI medical devices in controlled real world conditions before wider rollout, ensuring safety and effectiveness.
The new funding arrangement delivers £1.2 million each year from 2026 through 2029. This multi year commitment removes the limitations of annual budgeting and allows for more sustained and ambitious evaluations. The programme, which began as a pilot in 2024, has already explored complex regulatory questions around machine learning systems. These include tailored risk management approaches, the importance of linking AI outputs to reliable clinical data to minimise errors, and the need for ongoing post-market monitoring to track performance changes and address risks such as clinicians becoming overly dependent on the technology.
In its current phase, the AI Airlock focuses on practical challenges like AI-based diagnostic solutions, pre-determined change control plans, and applications seeking broader indications. Technologies examined so far range from voice assisted clinical tools and large language models to systems designed for detecting cancer and rare diseases. Insights gathered during this work will be shared publicly in mid-2026 through detailed reports and case studies aimed at guiding both technology developers and other regulators.
The initiative forms part of the UK government’s wider efforts to promote responsible innovation in healthcare. It aligns with several national strategies, including the Regulatory Action Plan and the AI Opportunities Action Plan. By building a more robust framework for AI as a medical device, the expanded programme is expected to help the UK maintain its position as a leader in safe and innovative health technologies while protecting patients.
“Securing this multi-year funding boost marks a pivotal moment for AI Airlock and for the safe and responsible advancement of AI in healthcare.”
By
HB Team
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