MHRA Commission Issues Recommendations on UK AI Regulatory Framework
核心洞察
An MHRA-created commission has issued 44 recommendations on the future UK regulatory framework for AI in healthcare, favoring lifecycle-based oversight over one-off pre-market assessments.
The commission proposes function-based regulation, staged-authorization pathways, updated medical device definitions and enhanced enforcement including financial penalties for non-compliant manufacturers.
Separately, the EMA opened consultation on a draft guideline for migraine (搜索) and cluster headache (搜索) trials, and MHRA published EHR guidance for UK clinical trial sites.
A commission established by the UK Medicines and Healthcare products Regulatory Agency (MHRA) has published 44 recommendations on the future regulatory framework for AI in healthcare. The National Commission into the Regulation of AI in Healthcare, created in September, concluded after a research and engagement program that regulation should move away from heavy reliance on one-off pre-market assessments toward a lifecycle-based approach, with a more tailored, flexible and proportionate framework.
The commission called on MHRA to systematically review and update the UK Medical Devices Regulations to accommodate software and AI-enabled devices, including revising the definition of a medical device to clarify exemptions for software used in healthcare administration, wellbeing or decision support. It also recommended function-based regulation, so that only capabilities classed as a medical device are reviewed, plus staged-authorization pathways in which authorization expands as prespecified evidence thresholds for performance and safety are met. Enhanced enforcement mechanisms could include financial penalties for manufacturers that fail to comply with legal requirements and place patients at risk. The government will now consider the advice.
In other European regulatory news, the European Medicines Agency (搜索) has opened consultation on a draft guideline covering clinical development of drugs for acute migraine (搜索) attacks and prevention of episodic and chronic migraine, with new advice on trial design, patient selection, endpoints and active comparators, plus recommendations for episodic and chronic cluster headache (搜索). Comments are open until 31 January. MHRA also published guidance on electronic health records to help UK trial sites comply with regulations, listing compliance issues such as inability to demonstrate investigator oversight and missing audit trails, and recommending an R&D representative on EHR project boards.
Source: RAPS