MHRA Secures £3.6m to Expand AI Regulatory Sandbox
The Medicines and Healthcare products Regulatory Agency (MHRA) has successfully secured a funding uplift aimed at expanding its AI Airlock programme, which serves as a regulatory sandbox for AI technologies deployed as medical devices.
Funding Allocation
In a significant move following a successful second phase of the programme, the Department of Health and Social Care (DHSC) has allocated £1.2 million annually for the next three years.
This funding will enable the programme to extend beyond the limitations of annual budgets, facilitating long-term testing models intended to create a more sustainable regulatory pathway for future AI medical technologies.
Significance of the Funding
James Pound, the executive director of innovation and compliance at the MHRA, remarked, “Securing this multi-year funding boost marks a pivotal moment for AI Airlock and for the safe and responsible advancement of AI in healthcare.”
Pound emphasized that the programme has already demonstrated how collaborative, real-world testing can help identify regulatory challenges early, thereby accelerating the delivery of high-quality and safe technologies to patients.
He further noted, “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.”
Programme Partnerships and Goals
The AI Airlock initiative is led by the MHRA in collaboration with the DHSC, NHS AI Team, and Team AB, a consortium of UK Approved Bodies. This programme is a crucial enabler for broader AI regulatory reform, aligning with government priorities such as the AI Opportunities Action Plan and the Life Sciences Sector Plan.
Industry Perspectives
Dr. Dom Pimenta, the chief executive and co-founder of TORTUS, an AI medical scribe supported by the NHS Innovation Accelerator, praised the programme’s cross-educational aspect, noting its value in enhancing understanding of regulatory objectives while sharing industry expertise at a time of rapid AI advancement.
He stated, “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.”
Previous Phases and Findings
The AI Airlock programme underwent an early pilot phase in 2024, with a second round of projects initiated in 2025. The pilot revealed several regulatory challenges associated with AI medical devices, highlighting the necessity for risk management strategies that address specific AI issues, such as minimizing errors through verified clinical information.
Furthermore, the pilot underscored the importance of improving how AI systems articulate their recommendations to bolster clinician confidence. It also emphasized the need for ongoing monitoring post-market to identify changes in performance and prevent user over-reliance.
Future Outlook
Phase two of the programme focuses on specific regulatory challenges related to AI-powered diagnostic tools, including pre-determined change control plans and the potential for AI devices to expand in their scope or intended use. This phase has explored various technologies, such as large language models and specialized diagnostics for cancer and rare diseases.
Reporting for phase two is anticipated to be published in Summer 2026, and insights from the AI Airlock initiative will contribute to the National AI Commission’s efforts regarding the future regulation of AI in healthcare.
