The Medicines and Healthcare Products Regulatory Agency has announced a regulatory sandbox that will allow up to ten AI medical device manufacturers to deploy their technologies in live NHS clinical settings under regulatory oversight, with the aim of generating real-world evidence that shortens the path to wider adoption across the health service.
The initiative, called London Region I, is a joint programme between MHRA, NHS England (London), and three London Health Innovation Networks: Imperial College Health Partners, UCLPartners, and HIN South London. Expressions of interest from both NHS providers and AI medical device manufacturers will open next month. The pilot runs until December 2028.
The programme is designed to address one of the recurring friction points in NHS AI adoption: the gap between regulatory approval based on controlled trial data and the real-world evidence commissioners and clinicians require before deploying a technology at scale. By running approved technologies in live settings under MHRA oversight, London Region I aims to generate outcomes data that satisfies both standards simultaneously.
"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," said Dame Caroline Clarke, Director of NHS London.
"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," said Lawrence Tallon, MHRA Chief Executive.
The sandbox sits within the NHS 10 Year Health Plan's mandate to accelerate technology adoption. MHRA said it is positioned to support collaboration between NHS providers and AI developers, matching technologies with system needs rather than running a parallel procurement process.
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