The MHRA has published the Phase 2 report of its AI Airlock programme, highlighting regulatory challenges related to AI medical devices, AI-powered IVDs, performance evaluation, post-market surveillance and lifecycle change management.

TGA publishes updated guidance on software-based medical devices. Key regulatory implications for manufacturers supplying SaMD in Australia.

The AI Airlock initiative, launched by the MHRA, is an innovative regulatory sandbox designed to support the development and evaluation of Artificial Intelligence medical devices (AIaMD). This controlled regulatory environment allows manufacturers of AI-based medical technology to test compliance approaches, clinical evidence and algorithmic validation prior to formal submission. With a focus on adaptive machine learning models, algorithmic security and continuous monitoring, AI Airlock represents a strategic opportunity to accelerate market access with UKCA compliance.