UK regulator pushes AI-era reforms for medicines and devices

The UK Medicines and Healthcare products Regulatory Agency is advancing a broad reform program across medicines, medical devices and clinical trials, with AI regulation, international reliance and faster development pathways at the center. A new liaison program with the U.S. Food and Drug Administration is intended to coordinate approaches to innovative medicines, medical devices and technologies such as AI, while the UK and U.S. are also working toward mutual recognition mechanisms for medical device approvals.

AI oversight is moving through several channels. The AI Airlock sandbox for AI as a Medical Device has secured further funding up to 2029, and Phase 2 highlighted challenges around realistic pre-market evidence, post-market monitoring, human oversight and clinically meaningful performance thresholds. MHRA is also supporting sandboxes for AI in medicines safety assessment and live clinical deployment of AI-enabled medical devices under regulator oversight.

Device reforms include consultation on indefinite recognition of CE-marked products and draft requirements for international reliance routes involving Australia, Canada and the U.S., alongside stronger post-market surveillance duties. MHRA also proposed a rare disease framework for conditions with a UK prevalence of no more than 1 in 50,000, launched clinical trial reforms described as the largest package in over 20 years, issued guidance on non-animal methods and began work on a pathway for space-manufactured medicines.