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More informationBlog post by Matthew Sanderson, Research Regulation Specialist
Med Tech Regs blog, June 2025: A focus on Software and AI.
Comments Deadline: 10th September 2025
From July 2025
The call for application for phase 2 of the AI Airlock is now open.
AI breakthroughs drive expansion of ‘Airlock’ testing programme to support AI-powered healthcare innovation
New MHRA CEO puts safety, accelerated access and innovation at the centre of agency’s refreshed strategic direction.
Since, April 2024, the MHRA has been using Lorenz DocuBridge for eCTD management in product license submissions. This change is part of the modernisation of the MHRA’s Legacy Systems and is one of the initial tools launched in the RegulatoryConnect programme.
New Post-Market Surveillance (PMS) regulations have taken effect across Great Britain, requiring medical device manufacturers to proactively monitor the safety and performance of their products once on the market.
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