UK Govt unveils AI Airlock to address challenges for regulating medical devices using AI

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Medicines and Healthcare products Regulatory Agency (MHRA), UK government, has set out its strategic approach to AI in response to a white paper published in 2023 by the government.

This pilot project is a key part of that approach. It will help the Agency to identify and address the challenges for regulating standalone artificial intelligence or AI medical devices (AIaMD), initially seeking out and supporting 4-6 virtual or real-world projects through simulation. This will allow us to test a range of regulatory issues for these devices when they are used for direct clinical purposes within the NHS.

The regulatory sandbox model is a recognised mechanism to help address novel regulatory challenges across sectors. The AI Airlock is a world-leading version in healthcare, designed to assist in safe development and deployment of AIaMDs, and this project will follow that robust process so manufacturers can deliver what is required to ensure the real-world viability of these devices.

The MHRA’s regulatory AI Airlock takes into account evidence-based work produced by other bodies with a similar focus and we will work collaboratively with the NHS AI Lab and the Department of Health and Social Care (DHSC). AIaMD products are deployed via NHS infrastructure, making the Devolved Nations crucial to regulatory discussions around deployment and post-market surveillance.

The findings from this partnership between government, regulators and industry will inform future AI Airlock projects and influence future UK and international AIaMD guidance, including how we work with UK Approved Bodies on UKCA marking and with trusted regulatory partners on international recognition of medical devices.