UK regulator brings new AI and MedTech agenda to AdvaMed

Speaking at the conference on Tuesday 20 October, Jessica Paulsen, MHRA Deputy Director for AI and Software, will outline the UK regulator’s developing approach to software and AI-enabled medical devices, including more flexible lifecycle regulation, regulatory sandboxes and closer international collaboration. 

She is speaking on following the publication of the MHRA 2030 Strategy, which sets out plans to modernise regulation for an era of AI and personalised medicine. For MedTech, this includes creating a modern, adaptive framework for AI as a medical device, establishing a new MHRA Centre for AI and Digital Health, improving device data and traceability, and expanding reliance and recognition routes with trusted international regulators, including the FDA.  

The MHRA 2030 strategy sets an ambition for the MHRA to deliver a global standard for safe and agile regulation of MedTech and AI by 2030, supporting faster access to innovative technologies while strengthening patient safety.  This month, the UK Government accepted all 44 recommendations of the NHS doctor-led independent National Commission into the Regulation of AI in Healthcare, supporting a more proportionate, lifecycle-based approach to AI regulation. 

The MHRA is already testing this approach through its AI Airlock, its regulatory sandbox for AI-enabled medical devices. It is complemented by a series of new regional partnerships including with NHS London and Manchester University NHS Foundation Trust, leveraging the UK’s unique healthcare system and academic excellence to test innovative technologies in real health settings and generate evidence to inform future regulatory approaches. 

Together, this work will help the MHRA develop regulation that can respond to AI-enabled devices that evolve throughout their lifecycle, while giving developers greater clarity on regulatory requirements. 

Jessica Paulsen, MHRA Deputy Director for AI and Software, said: