The Medicines and Healthcare Products Regulatory Agency (MHRA) has launched AI Airlock, its new regulatory sandbox for AI as a medical device (AIaMD).
The project will help the Agency identify and address the challenges of regulating standalone AI medical devices.
Initially, it will seek out and support four to six 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 project also builds on MHRA’s strategic approach to AI, which was set out in a white paper published by the government in 2023.
Safely developing and deploying AI medical devices
The regulatory sandbox model is a recognised mechanism to help address novel regulatory challenges across the health technology sector.
The AI Airlock is a world-leading version of healthcare designed to assist in the safe development and deployment of AIaMDs.
The project will follow that robust process so manufacturers can deliver what is required to ensure the real-world viability of these devices.
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.
Addressing patient and public needs
This fact-finding approach is key to safeguarding patients as we learn about the full potential of this technology.
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.
Dr Paul Campbell, MHRA Head of Software and AI, said: “We are currently seeing a marked increase in innovative AI medical devices 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.”
He concluded: “The launch of the AI Airlock will enhance our collective understanding and accelerate solutions to novel regulatory challenges, ultimately improving the experience of patients.”
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.
