The MHRA has secured a major funding uplift to expand its pioneering AI Airlock programme, the UK’s first regulatory sandbox for Artificial Intelligence as a Medical Device (AIaMD).
Following a successful second phase, the Department of Health and Social Care (DHSC) has allocated £1.2 million per year for the next three years (2026–2029) to the programme.
The newly approved multi‑year funding will enable the AI Airlock programme to scale beyond the constraints of yearly financial cycles. This will support more ambitious, longer-term testing models while helping to create a more sustainable regulatory pathway for future AI medical technologies.
AI Airlock is led by the MHRA in partnership with DHSC, NHS AI Team, and Team AB (the consortium of UK Approved Bodies).
AI Airlock has continued to grow since the launch and early pilot phase in 2024, with a second round of projects opening in 2025.
Phase two of the programme includes specific regulatory challenges for AI-powered diagnostic tools, pre-determined change control plans (PCCPs), and how AI devices may expand in scope or intended use. The phase has explored a diverse range of technologies, including large language models, voice tools, and specialised diagnostics for cancer and rare diseases. So far, AI Airlock has produced a series of reports and case studies to support learning across the sector.
Reporting for phase two is expected to be published in Summer 2026. Together with the pilot findings they will inform the design of phase three and continue to shape the MHRA’s broader approach to AI regulation.
Insights from the AI Airlock are contributing to the National AI Commission’s work on the future regulation of AI in healthcare.
