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听AI听础颈谤濒辞肠办
罢丑别听MHRA听AI听础颈谤濒辞肠办 was launched in Spring 2024 and is the MHRA鈥檚 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听AIaMD.
Using real-world products, the听AI听础颈谤濒辞肠办 will bring together expertise from within the听MHRA听and key partners including the UK Approved Bodies, the听NHS听and other regulators. The outputs will inform subsequent听AI听础颈谤濒辞肠办 phases in the short term, and future听MHRA听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 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.听
Applications for phase 2 have now closed and more information can be found here.
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.
AI Airlock pilot cohort
The pilot phase of the AI Airlock has now completed. The pilot cohort each addressed a specific regulatory challenge as part of the pilot and reports from the pilot will be available later this year. 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.
Webinar recording
Review the AI Airlock webinar 鈥� Pilot and Phase 2, which took place on Thursday 19 June 2025
Project newsletters and press releases
26 March 2025 - Blog
Updates to this page
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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.