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More information9th June 2026
Summary: The MHRA has published insights from Phase 2 of its AI Airlock programme, the UK's regulatory sandbox designed to explore the challenges of regulating Artificial Intelligence as a Medical Device (AIaMD). Building on the success of the pilot phase, the programme brings together regulators, developers, clinicians and healthcare organisations to test innovative AI technologies in a controlled environment. Phase 2 focuses on key regulatory issues including adaptive AI systems, AI-powered diagnostics, intended use boundaries, post-market surveillance and ongoing monitoring of AI performance. The findings will help inform future MHRA guidance and recommendations from the National Commission into the Regulation of AI in Healthcare, supporting the safe and effective adoption of AI technologies across the NHS while maintaining patient safety and public confidence.