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 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.
Applicants can now apply to join the AI Airlock Phase 2 cohort 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 application window for the 2024 pilot cohort is now closed and applications have been sifted and prioritised against the eligibility criteria. The pilot cohort have been selected for the pilot project and each will address and 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.
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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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.