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.
The second phase of the Airlock is now complete after testing a complex set of regulatory challenges. The MHRA announced on the 8th April that funding has been secured to continue the AI Airlock Programme. The newly approved multi‑year funding will enable the programme to scale beyond the constraints of yearly financial cycles. This will support more ambitious, longer-term testing models while helping to create a more sustainable regulatory pathway for future AI medical technologies.
Designing of the Phase 3 sandbox programme is in progress, and more information is due to be announced later in the year.
This webpage contains information about the programme, the key partners, the innovators that have participated in the Airlock and the comprehensive reports from the case studies and programme phases.
AI Airlock programme reporting
The pilot programme closed in April 2025 and focused on four 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 second phase of the Airlock completed in May 2026 and focused on 7 innovators across 3 regulatory challenges.
The reports for the AI Airlock’s first and second phases of the 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 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 workshop reports
A key part of the testing within the AI Airlock programme are the Simulation workshops. These are focused roundtable workshops designed to bring together multiple stakeholder perspectives. Reports summarising these workshops held during the AI Airlock pilot and second phase are available. Each document contains key insights from the Simulation workshops that were hosted by the MHRA. These documents are not formal MHRA guidance.
Details
During the AI Airlock programme, the MHRA hosted Simulation workshops exploring key regulatory challenge areas.
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 innovators
Since its launch in 2024 the AI Airlock has now completed 2 testing phases with 11 innovators across 7 regulatory challenges.
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.
Phase 2 of the Airlock included 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.
Webinar recording
Review the AI Airlock webinar – Pilot and Phase 2, which took place on Thursday 19 June 2025
How to watch this YouTube video There should be a YouTube video on this page. I you cannot see or access it, this maybe because of your cookie settings. Here you can review the AI Airlock webinar – Pilot and Phase 2, which took place on Thursday 19 June 2025
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 and second phases and as we move into phase 3, 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