Guidance
AI Airlock Sandbox Pilot Programme Report
The MHRA’s AI Airlock pilot phase ran between April 2024 and March 2025. This report does not constitute formal MHRA guidance.
Documents
Details
The AI Airlock programme report contains a comprehensive overview of the methodology for establishing the regulatory sandbox, the four pilot case studies and the lessons learned from the independent programme evaluation. This report also summarises the key technical and regulatory insights and recommendations for changes to the regulatory and support framework for AI as a medical device.
Updates to this page
Published 16 October 2025