MHRA AI Airlock — the UK's First Regulatory Sandbox for AI Medical Devices, 40 Applicants, 4 Completed, Now Funded to 2029

The AI Airlock is the UK's first regulatory sandbox for Artificial Intelligence as a Medical Device (AIaMD), run by the MHRA in partnership with the NHS and the Department of Health and Social Care. The pilot was launched in May 2024 and ran to March 2025.
A public call drew 40 applications (31% generative AI, 23% machine learning); 5 were taken forward and 4 completed the full pilot. Each used a four-stage model (orientation, plan, test, review) across simulation, virtual and real-world testing environments, with regulatory gap analyses as outputs.
The MHRA published a 77-page pilot report in October 2025 with recommendations for AIaMD guidance, covering topics such as synthetic data, explainability and post-market monitoring. A second cohort of seven innovators was announced in October 2025, and in April 2026 the MHRA announced £3.6m over three years (£1.2m a year, 2026–2029).
Caveat: the pilot cohort was tiny and outputs are regulatory recommendations; no patient-outcome impact is yet evidenced, and testing in the real-world environment did not use AI outputs to make patient decisions.

Read the full analysis: https://assets.publishing.service.gov.uk/media/68ee1fb88427701993d5e02c/AI_Airlock_Sandbox_Programme_Report_Final.pdf