Latest / Medical Device Global Market Access
UK MHRA AI Medical Device Rules: What the New Lifecycle Framework Means for Manufacturers
The UK government has committed the MHRA to a new lifecycle-based regulatory framework for AI-enabled medical devices, moving away from one-time pre-market assessments to continuous monitoring. This episode breaks down the October 6, 2026, announcement, detailing the upcoming deadlines for draft guidance by December 2026 and a full implementation roadmap by Spring 2027. We discuss how manufacturers can engage with the MHRA's AI Airlock sandbox and outline practical steps for adapting post-market surveillance systems and technical documentation to meet these evolving requirements. Key…
The skinny
The skinny isn't ready yet — notes appear once the transcript is processed.