AI Airlock: a regulatory sandbox for AI enabled Medical Devices
A proactive, collaborative, first of its kind approach to identifying and addressing the challenges faced by AI enabled Medical Devices.
About the AI Airlock
The MHRA AI Airlock was launched in Spring 2024 and is the MHRA’s first exploratory regulatory sandbox for AI enabled Medical Devices. The programme enhances our understanding and accelerates solutions to novel regulatory challenges for AI enabled medical devices.
The AI Airlock brings together expertise from within the MHRA and key partners including industry, healthcare system partners both in and out of the NHS, as well as other regulators and the wider regulatory community. The AI Airlock’s outputs will help to inform a fit-for-purpose regulatory framework for AI-enabled Medical Devices in Great Britain, in line with the recommendations of the National Commission into the regulation of AI in healthcare.
The MHRA announced on 6th October 2026 the launch of the third phase of the AI Airlock. Supported by multi‑year funding from the Department for Health and Social Care, the Airlock will be able to centre around more ambitious, longer-term testing models focused on producing tangible outputs and forwarding agency priorities.
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 call for applications
Applications are being accepted for innovators to join the third phase of the AI Airlock. The current wave of the programme will be focused on regulatory challenges around post-market surveillance and broader oversight of AI-enabled Medical Devices throughout a device’s lifecycle.
Candidates can submit applications to join the programme using the forms below.
AI Airlock programme reporting
The pilot programme closed in April 2025 and focused on four products across a range of medical device regulatory issues. The second phase of the Airlock completed in May 2026 and focused on 7 innovators across 3 regulatory challenges. Each coming from different sections of healthcare or clinical disciplines and at varying levels of product regulatory maturity.
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 informed the MHRA’s National Commission into the Regulation of AI in Healthcare which brought 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 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.
Phase 3 is now open for applications and selected participants will be outlined here when onboarded. Phase 3 will welcome applications from a broader range of candidates who would like to propose potential solutions to, and explore, the stated regulatory challenges, including but not limited to medical devices manufacturers, academics and developers of related, innovative solutions.
Webinar recording
The AI Airlock programme will be hosting a webinar on the 22nd October 2026 and registration can be found here:
AI Airlock Phase 3 Webinar Registration.
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 enabled Medical Devices. 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 AI enabled Medical Devices. 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