The Medicines and Healthcare products Regulatory Agency (MHRA) has launched AI Airlock – its new regulatory sandbox for AI as a Medical Device (AIaMD).
The Airlock aims to help the agency to identify and address the challenges for regulating standalone AIaMD, initially seeking out and supporting four to six virtual or real-world projects through simulation.
The new process will enable the health body 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 will follow this robust process so manufacturers can deliver what is required to ensure the real-world viability of these 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.”
The findings from the partnership between government, regulators and industry will inform future AI Airlock projects and influence future UK and international AIaMD guidance.
This will include how the MHRA works with UK Approved Bodies on UKCA marking and with trusted regulatory partners on international recognition of medical devices.
MHRA’s regulatory sandbox is an expanding offering in the health tech space, and with investment in innovative solutions aiming to position the NHS as an industry leader by 2030.
Dr Campbell added: “The launch of the AI Airlock will enhance our collective understanding and accelerate solutions to novel regulatory challenges, ultimately improving the experience of patients.”
