MHRA’s AI Airlock Pilot Project Revolutionizing AI Medical Device Regulation

The MHRA have started a pilot project in response to a white paper published in 2023 by the UK government which will address the challenges for regulating AI medical devices (AIaMD). The AI Airlock (the regulatory sandbox model) is a world-leading version in healthcare and will be used to test a range of medical device regulatory issues in 4-6 virtual or real-world projects. The MHRA will launch a call for product applications shortly, and the AI Airlock will open for applications after the project webinar on 5th June 2024. 

AI Airlock will work with the NHS AI lab and the Department of Social Care (DHSC) so it can incorporate evidence-based work collaboratively. 

There has been an increase in AIaMD products in the UK market and the findings of the pilot will influence future UK and international guidance on AIaMD.  

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If you have questions about the MHRA’s new pilot project, or need assistance in navigating regulatory compliance in the UK, contact us so we can help you. 

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