The Medicines and Healthcare products Regulatory Agency (MHRA) has announced a significant funding boost to enhance its AI Airlock programme, the United Kingdom’s inaugural regulatory sandbox for Artificial Intelligence as a Medical Device (AIaMD). Following the programme’s successful second phase, the Department of Health and Social Care (DHSC) has committed £1.2 million annually for the next three years, from 2026 to 2029, to support this initiative.
This multi-year funding will allow the AI Airlock to transcend the limitations of annual financial cycles, enabling the programme to pursue more ambitious and long-term testing models. It aims to establish a sustainable regulatory pathway for future AI medical technologies, ensuring patient safety while fostering innovation in healthcare.
AI Airlock is spearheaded by the MHRA in collaboration with the DHSC, the NHS AI Team, and Team AB, a consortium of UK Approved Bodies. This programme is pivotal for broader AI regulatory reform, aligning with government priorities as outlined in the AI Opportunities Action Plan, the Regulatory Action Plan, and long-term strategic initiatives such as the 10-Year Health Plan and the Life Sciences Sector Plan.
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James Pound, Executive Director of Innovation and Compliance at the MHRA, described the funding as a “pivotal moment for AI Airlock and for the safe and responsible advancement of AI in healthcare.” He emphasized that the programme has already demonstrated how collaborative, real-world testing can identify regulatory challenges early, facilitating the swift introduction of high-quality, safe technologies to patients. “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,” he added.
Dr. Dom Pimenta, CEO and Co-founder of TORTUS AI, highlighted the unique opportunity presented by the AI Airlock programme to unite stakeholders around critical areas in clinical AI. He noted that the initiative has been invaluable for deepening understanding of regulatory objectives and sharing industry expertise amid rapid advancements in AI. “The extension of this initiative is fantastic news,” he remarked, “as it has the potential to set a global benchmark for safe, effective, and rapid deployment of clinical AI solutions.”
Since its launch and early pilot phase in 2024, AI Airlock has continued to evolve, with a second round of projects set to open in 2025. The pilot identified key regulatory challenges associated with AI medical devices, revealing that risk management must address issues unique to AI, such as minimizing errors and inaccuracies through methods that ground model responses in verified clinical data. It also underscored the necessity of improving AI systems’ ability to explain their recommendations, which is essential for clinician confidence. Additionally, the pilot highlighted the importance of ongoing monitoring for market products to track any performance changes or potential over-reliance by users.
Phase two of the programme builds on these findings, addressing specific regulatory challenges for AI-powered diagnostic tools, predetermined change control plans (PCCPs), and considerations for how AI devices may expand their scope or intended use. The phase has explored a variety of technologies, including large language models, voice tools, and specialized diagnostics for cancer and rare diseases. To date, AI Airlock has generated a series of reports and case studies aimed at fostering sector-wide learning.
Reporting for phase two is expected to be published in Summer 2026, and together with the pilot findings, it 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 also contributing to the National AI Commission’s work on future AI regulation in healthcare.
By fostering collaboration between industry and regulators, AI Airlock aims to strengthen the healthcare system and provide solutions to real-world challenges. This initiative supports safe innovation and a more coordinated approach to regulating AI medical devices. It remains central to the MHRA’s ongoing efforts to develop a robust and futureproof regulatory framework for medical devices, underscoring the agency’s commitment to patient safety, responsible AI innovation, and maintaining the UK’s attractiveness as a market for medical technology innovators.
Launched in Spring 2024, the AI Airlock programme is a groundbreaking effort by the MHRA to create a regulatory environment conducive to AIaMD products. Further details regarding the design and application process for phase three will be announced later this year. The MHRA, as an executive agency of the Department of Health and Social Care, is responsible for regulating all medicines and medical devices in the UK, ensuring their efficacy and safety through rigorous, evidence-based assessments.
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