The Medicines and Healthcare products Regulatory Agency (MHRA) has secured a £3.6m ($4.8m) funding increase over three years to expand the AI Airlock programme, the UK’s regulatory sandbox for AI as a medical device (AIaMD).

The Department of Health and Social Care (DHSC) will provide £1.2m annually from 2026 to 2029 for the programme, supporting broader, long-term evaluations and advancing sustainable regulatory pathways for AI healthcare technologies.

According to the MHRA, this funding removes constraints of annual budgeting and enables more ambitious testing models.

AI Airlock is jointly run by the MHRA, DHSC, National Health Service (NHS) AI Team, and Team AB, the consortium of UK Approved Bodies.

It is designed as a cornerstone for AI regulatory reform and aligns with broader government initiatives across the Regulatory Action Plan, the AI Opportunities Action Plan, the 10-Year Health Plan, and the Life Sciences Sector Plan.

AI Airlock has experienced continuous growth since its launch and initial pilot phase in 2024. This phase revealed various areas where AI medical devices present new regulatory challenges.

It demonstrated that risk management must address issues unique to AI, such as minimising errors and inaccuracies by employing techniques that anchor model responses in validated clinical data.

The pilot emphasised the necessity for ongoing monitoring after products are introduced to the market, to detect any changes in performance or excessive reliance by users.

The current phase continues to address regulatory challenges for AI-driven diagnostic technologies, pre-determined change control plans, and possible expansions of device use.

It explored a range of technologies such as voice tools, large language models, and diagnostics for cancer and rare diseases, providing guidance via reports and case studies.

Findings from the current phase are expected in mid-2026.

MHRA innovation and compliance executive director James Pound 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.

“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.”

In February, the MHRA reported a record number of device trial approvals in the UK last year.