The MHRA has secured £3.6m to expand AI Airlock, the UK’s first regulatory sandbox for AI medical devices.
Following a successful second phase, the Department of Health and Social Care has allocated £1.2m a year for the next three years, from 2026 to 2029, to the programme.
The newly approved multi-year funding will allow the AI Airlock programme to scale beyond the limits 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.
James Pound, executive director of innovation and compliance, said:
“Securing this multi-year funding boost marks a pivotal moment for AI Airlock and for the safe and responsible advancement of AI in healthcare.
“The programme has already shown how collaborative, real-world testing can uncover regulatory challenges early and help innovators bring high-quality, safe technologies to patients faster.
“This additional investment will allow us to scale up and ultimately strengthen our ability to ensure that AI-powered medical devices can reach patients safely, efficiently and with the confidence of robust regulatory oversight.”
AI Airlock is led by the MHRA in partnership with the Department of Health and Social Care, the NHS AI Team and Team AB, the consortium of UK Approved Bodies.
The programme is a key enabler of wider AI regulatory reform and aligns with government priorities across the AI Opportunities Action Plan, the Regulatory Action Plan and long-term strategic programmes including the 10-Year Health Plan and the Life Sciences Sector Plan.
Dr Dom Pimenta, chief executive and co-founder of TORTUS AI, said: “The AI Airlock programme represents a unique and critical opportunity to bring together stakeholders around high-priority areas in clinical AI, helping to chart a clear and actionable path forward.
“At TORTUS, we’ve found the cross-educational aspect of the programme particularly valuable, both in deepening our understanding of regulatory objectives and in sharing industry expertise at a time when AI is advancing at an unprecedented pace.
“The extension of this initiative is fantastic news, as it has the potential to set a global benchmark for safe, effective, and rapid deployment of clinical AI solutions.”
AI Airlock has continued to grow since its launch and early pilot phase in 2024, with a second round of projects opening in 2025.
The pilot highlighted several areas where AI medical devices raise new regulatory challenges.
It showed that risk management must consider issues specific to AI, such as reducing errors and inaccuracies by using techniques that ground model responses in verified clinical information.
It also found that improving how AI systems explain their recommendations is crucial for supporting clinician confidence.
The pilot underlined the need for ongoing monitoring once products reach the market, to identify changes in performance or over-reliance by users.
Phase two of the programme builds on this work and includes specific regulatory challenges for AI-powered diagnostic tools, pre-determined change control plans and how AI devices may expand in scope or intended use.
The phase has explored a diverse range of technologies, including large language models, voice tools and specialised diagnostics for cancer and rare diseases.
So far, AI Airlock has produced a series of reports and case studies to support learning across the sector.
Reporting for phase two is expected to be published in summer 2026.
Together with the pilot findings, this will inform the design of phase three and continue to shape the MHRA’s broader approach to AI regulation.
