CLOSED AI Airlock Phase 2 application

AI Summary

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced a call for applications for Phase 2 of its AI Airlock programme. This initiative serves as a regulatory sandbox designed to help developers of artificial intelligence-based medical devices navigate the complexities of the UK Medical Devices Regulation 2002. The program aims to select up to four candidates to explore regulatory challenges across various clinical disciplines and stages of product development. Participating companies will collaborate with a partnership of experts, including the Department of Health and Social Care and the Information Commissioner’s Office, to de-risk innovative products before they enter the market. Testing will occur in three distinct environments: Simulation (stakeholder focus groups), Virtual (digital stress-testing), and Real-World (clinical workflow testing without impacting patient outcomes). To be eligible, applicants must be legal entities with the rights to market their products in the UK, demonstrate their product's innovative potential for patient benefit, and present a clear regulatory challenge. While there are no fees for participation or expert advice, companies must commit their own resources and fund their specific data access and testing costs. The application deadline is July 14, 2025. Following a shortlisting process, selected candidates will enter a testing phase lasting approximately six months, with the overall program concluding in April 2026. The final outputs will include project reports and learnings to inform future regulatory guidance for AI technologies in healthcare.