AI Airlock: the regulatory sandbox for AIaMD
A proactive, collaborative, agile and the first of its kind approach to identifying and addressing the challenges faced by AI as a Medical Device (AIaMD).
About the AI Airlock
The MHRA AI Airlock was launched in Spring 2024 and is the MHRA’s first regulatory sandbox for AI as a Medical Device (AIaMD) products. The project will enhance our understanding and accelerate solutions to novel regulatory challenges for AIaMD.
Using real-world products, the AI Airlock will bring together expertise from within the MHRA and key partners including the UK Approved Bodies, the NHS and other regulators. The outputs will inform subsequent AI Airlock phases in the short term, and future MHRA guidance and policy in the longer term, while exploring any limitations of existing approaches to demonstrating regulatory compliance.
This webpage contains information about the project, the key partners, pilot cohort candidates and some examples of potential issues we expect to address in the project.
AI Airlock pilot programme reporting
The pilot programme closed in April 2025. Initially focusing on a small number of products, across a range of medical device regulatory issues. Each coming from different sections of healthcare or clinical disciplines and at varying levels of product regulatory maturity.
The reports for the AI Airlock pilot programme are now available. These reports do not constitute formal guidance. They are comprehensive reports on the regulatory sandbox methodology that was employed, results from the AI Airlock pilot case studies and the independent programme evaluation.
The in-depth insights from real-world technologies through the Airlock will inform recommendations to the MHRA’s National Commission into the Regulation of AI in Healthcare which brings together clinicians, regulators, and tech companies to advise the MHRA on AI regulation in healthcare
AI Airlock simulation reports
Three Simulation workshop reports from the AI Airlock pilot programme. Each document contains key insights from a Simulation workshop that was hosted by the MHRA as part of the AI Airlock pilot testing. These documents are not formal MHRA guidance.
Details
During the AI Airlock pilot phase, the MHRA hosted 3 Simulation workshops exploring key regulatory challenge areas: Explainability in AI as a Medical Device, Evaluating hallucinations in AI for healthcare and post-market surveillance and continuous monitoring for AI as a Medical Device.
Each session brought together a diverse group of representatives from across industry, clinical practice, regulation, academia and technology. Participants included experts from the MHRA, NICE, NHS and a range of partner organisations. Their insights and collaborative contributions were instrumental in shaping the discussions and recommendations outlined in these reports.
AI Airlock pilot cohort
Webinar recording
Review the AI Airlock webinar – Pilot and Phase 2, which took place on Thursday 19 June 2025
Review the AI Airlock webinar – Pilot and Phase 2, which took place on Thursday 19 June 2025
The pilot phase of the AI Airlock has now completed. Each addressed a specific regulatory challenge as part of the pilot. Read more about the pilot cohort.
The pilot programme ran until April 2025 and initially focus on a small number of products, across a range of medical device regulatory issues, within different sections of healthcare or clinical disciplines and levels of product regulatory maturity.
AI Airlock Phase 2
The Government announced in its Regulatory Action Plan on the 17 March 2025 that the AI Airlock will run another phase during the 2025-2026 financial year.
Phase 2 of the Airlock will include seven additional technologies spanning AI-powered clinical note taking, advanced cancer diagnostics, eye disease detection tools, and obesity treatment support systems. This expansion addresses three fundamental regulatory challenges around managing evolving AI applications, regulating AI-powered diagnostics effectively, and implementing robust post-market surveillance for AI medical devices.
Candidates will test in the Airlock until March 2026 when the second phase will be finalised.
Applications for phase 2 have now closed and can be found below.
AI Airlock Background
The AI Airlock was established to proactively investigate the regulatory challenges of AI as a Medical Device. Working with key partners during the pilot phase and as we move into phase 2, the programme is working towards key project outputs including an improved regulatory guidance for AIaMD. This page contains some of the background information for the programme.
Project newsletters and press releases
Exploring AI in Healthcare: Insights from the AI Airlock Pilot
26 March 2025 - Blog
Updates to this page
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Updated to add quote from Lord Vallance
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Introduction of new pages outlining and hosting the pilot programme reports and the new phase 2 cohort
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Updated to fix typo in paragraph AI Airlock Pilot cohort
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Update to reflect that the pilot phase of the AI Airlock is complete, and that applications for phase 2 have now closed
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AI Airlock webinar recording link added.
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Webpage has been simplified, added the background context into a separate page Added new phase 2 detail to main page and a new page for the application form
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Published link to webinar for 19 June 2025
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Page updated to include a link to a blog about AI Airlock.
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Press Release added 'MHRA trials five innovative AI technologies as part of pilot scheme to change regulatory approach'.
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Updated to include information about the five technologies selected for the AI Airlock pilot.
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Added AI Airlock application documents to collection
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Link to July webinar video added.
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First published.