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MHRA launches AI Airlock to address AI regulatory challenges

By May 14, 2024May 15th, 2024No Comments

Last month, the MHRA set out its strategic approach to AI in response to a white paper published in 2023 by 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 AI medical devices (AIaMD), initially seeking out and supporting 4-6 virtual or real-world projects through simulation. This will allow for testing 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 designed to assist in safe development and deployment of AIaMDs.

The MHRA’s regulatory AI Airlock takes into account evidence-based work produced by other bodies with a similar focus and they 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 the MHRA work with UK Approved Bodies on UKCA marking and with trusted regulatory partners on international recognition of medical devices.

Ben Kemp