MHRA launches "AI Airlock": new regulatory sandbox for medical devices based on Artificial Intelligence

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.