MHRA launches AI Airlock to address challenges for medical devices that use Artificial Intelligence

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched AI Airlock, its new regulatory sandbox for AI as a Medical Device (AIaMD). The regulatory sandbox model will helps safely develop and deploy AIaMDs. This project will follow a thorough process to ensure these devices are viable in the real world.

Last month, the MHRA outlined its strategy for regulating AI in response to a government white paper. This new pilot project aims to address challenges in regulating standalone AI medical devices (AIaMD) by initially supporting 4-6 projects. The goal is to test regulatory issues for these devices when used in the NHS.

The regulatory sandbox model, called the AI Airlock, helps safely develop and deploy AIaMDs. This project will follow a thorough process to ensure these devices are viable in the real world. The MHRA will work with the NHS AI Lab and the Department of Health and Social Care (DHSC) on this initiative.

The findings will shape future AI Airlock projects and influence AIaMD guidelines in the UK and internationally, including UKCA marking and global recognition of medical devices.

Dr. Paul Campbell, MHRA Head of Software and AI, noted that innovative AIaMD products are rapidly entering the UK market, offering new ways to meet patient needs. The MHRA aims to balance safety oversight with the flexibility needed to support innovation.

The AI Airlock will help understand and solve regulatory challenges, improving patient experiences and ensuring safe use of AIaMDs. This initiative will also build trust between developers, manufacturers, and the MHRA, ultimately benefiting patient engagement and safety.

The MHRA’s regulatory sandbox is growing, with investments to position the NHS as a leader in healthcare technology by 2030.

Access to the AI Airlock:

https://www.gov.uk/government/collections/ai-airlock-the-regulatory-sandbox-for-aiamd