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UK Launches New MHRA Regulatory Sandbox for AI-Enabled Medical Devices: What London Region I Means for Regulatory Affairs
The MHRA AI regulatory sandbox for medical devices, known as London Region I, allows up to 10 AI-enabled medical device manufacturers to deploy their technologies in real NHS clinical settings under regulatory oversight while generating real-world safety and effectiveness evidence. This affects AI medical device manufacturers, NHS providers across London, and UK regulatory affairs professionals working in medical devices. It applies from the Expression of Interest stage opene
4 days ago13 min read