The Medicines and Healthcare products Regulatory Agency (MHRA)
has secured a major funding uplift to expand its pioneering AI
Airlock programme, the UK's first regulatory sandbox for
Artificial Intelligence as a Medical Device (AIaMD).
Following a successful second phase, the Department of Health and
Social Care (DHSC) has allocated £1.2 million per year
for the next three years (2026–2029) to the programme.
The newly approved multi‑year funding will enable the AI
Airlock 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.
AI Airlock is led by the MHRA in partnership with DHSC,
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.
James Pound, Executive Director, 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.
Dr Dom Pimenta, CEO and Co-founder, 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 the 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 (PCCPs), 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 they will inform the design of
phase three and continue to shape the MHRA's
broader approach to AI regulation.
Insights from the AI Airlock are contributing
to the National AI Commission's work on the
future regulation of AI in healthcare
The AI Airlock strengthens the healthcare system
by helping industry and regulators to work
together on real-world challenges. This
supports safe innovation and a more coordinated approach
to regulating AI medical devices.
AI Airlock remains central to the MHRA's wider
programme of work to develop a robust, futureproof regulatory
framework for medical devices. The
MHRA remains committed to prioritising patient safety,
enabling responsible AI innovation, and ensuring the
UK remains an attractive market for medical technology
innovators.
Notes to editors:
-
The programme was launched in Spring 2024 and is the MHRA's
first regulatory sandbox for AI as a Medical Device (AIaMD)
products.
-
Further details regarding the AI
Airlock phase three design and call for
applications will be made available later in the
year.
-
The Medicines and Healthcare products Regulatory Agency
(MHRA) is responsible for regulating all medicines and
medical devices in the UK by ensuring they work and are
acceptably safe. All our work is underpinned by robust and
fact-based judgements to ensure that the benefits justify any
risks.
