UK MHRA AI Medical Device Regulation: New Lifecycle Approach and AI Airlock Phase 3

Podcast: Medical Device Global Market Access · Pure Global

Opublikowano: 2026-10-09

The UK government has accepted all 44 recommendations for regulating AI in healthcare, marking a major policy shift for the MHRA. As of October 6, 2026, the UK is moving from a single pre-market approval to a lifecycle-based regulatory approach for AI-enabled medical devices. This episode breaks down what this new framework means for manufacturers, including the immediate opening of applications for Phase 3 of the AI Airlock sandbox, an upcoming applicant webinar on October 22, 2026, and the MHRA's commitment to release draft guidance on managing AI device changes by December 2026. We discuss the implications for post-market surveillance and provide actionable steps for regulatory, quality...