The AI Airlock programme, which is led by the MHRA in partnership with DHSC, NHS AI Team, and Team AB (the consortium of UK Approved Bodies), aims to 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, innovation and compliance, said: ‘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.'

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. 

The AI Airlock pilot, which launched in 2024, has highlighted 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 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.

Dr Ben Turner, medical evidence lead, Heidi, said: ‘If we get this right, AI can reduce unwarranted variation and bring high quality evidence into decisions at the bedside much faster. The UK has a real opportunity to set the global benchmark for how AI in healthcare is regulated, giving the NHS confidence that tools meet consistently high standards rooted in evidence and backed by ongoing scrutiny.'