Pioneering AI health innovations regulatory sandbox launched

Expressions of Interest are now open for the London Region I AI Regulatory Sandbox.

AI medical device manufacturers and London-based NHS providers are invited to submit an Expression of Interest to participate in the programme and support the evaluation of AI-enabled medical devices in real-world NHS settings. Further information, including eligibility criteria and application details, is available in the call for applications.

Patients across London are set to benefit from faster access to innovative, AI‑powered healthcare technologies, as the Medicines and Healthcare products Regulatory Agency (MHRA), in partnership with NHS England (London) and the London Health Innovation Networks (HINs), today announces a new regulatory sandbox.

The initiative, known as London Region I, will create a real-world environment to safely deploy AI-enabled medical devices while generating additional evidence of benefit across NHS settings, helping ensure patients can access new technologies earlier while maintaining the highest standards of safety.

By bringing together regulators, healthcare providers and innovators, the sandbox provides a controlled environment so cutting-edge technologies can be safely and securely deployed. The programme will support delivery of the NHS 10 Year Health Plan by enabling faster adoption of technologies that improve patient outcomes, expand access to care, and reduce health inequalities.

Up to 10 AI medical device manufacturers will be selected to participate in the initial phase, working alongside NHS providers across London to deploy technologies in live clinical settings under MHRA oversight.

By enabling controlled, outcomes-based deployment, the sandbox aims to generate robust real-world evidence on safety and effectiveness while supporting a clearer, more predictable route to wider adoption.

MHRA will be inviting expressions of interest from both NHS providers and AI medical device manufacturers interested in participating in London Region I next month.  The programme will support collaboration between providers and innovators, helping to match technologies with real system needs and enabling rapid, evidence-led deployment in practice.

Dame Caroline Clarke, Director NHS London, said:

“Londoners deserve the best that modern medicine has to offer. This programme is about making sure the NHS in London can adopt the latest technologies quickly, safely and in a way that genuinely improves care for patients. We want London to lead the way in developing and scaling-up innovation, demonstrating its value in the real world for Londoners and making London even more attractive for the Life Science sector.

Lawrence Tallon, MHRA Chief Executive, said:

“This initiative demonstrates that regulation can be an enabler for innovation, not a barrier.

“We need to work faster to keep pace with developments in AI to ensure that patients can safely benefit from cutting-edge technologies as they become available.”