The Medicines and Healthcare products Regulatory Agency (MHRA) has launched AI Airlock, its new regulatory sandbox for AI as a Medical Device (AIaMD). This initiative aims to address challenges for regulating medical devices that use AI.
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 between four and six virtual or real-world projects through simulation. This will allow MHRA 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 it 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 MHRA works with UK Approved Bodies on UKCA marking and with trusted regulatory partners on international recognition of medical devices.
Dr Paul Campbell, MHRA Head of Software and AI, said: “We are currently seeing a marked increase in innovative AIaMD products entering the UK market that have the potential to revolutionise the healthcare landscape and provide improved ways to address patient and public needs. As a regulator, we must balance appropriate oversight to protect patient safety with the agility needed to respond to the particular challenges presented by these products to ensure we continue to be an enabler for innovation.”
Where AI Airlock can enhance the relationship between developers and manufacturers with the MHRA as a regulatory body, in the future it may also serve to support confidence in patient engagement and the safe use of AIaMD products.
MHRA’s regulatory sandbox is an expanding offering in the healthcare technology space, and investment in innovative solutions is underway to position the NHS as an industry leader by 2030.
Visit the AI Airlock webpage for latest updates on the project.