UK’s Medicines and Healthcare products Regulatory Agency (MHRA) sets out its next phase of MedTech and AI regulation to US industry leaders at AdvaMed 2026.
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:
“AI is changing medical technology, and regulation must keep pace. In the UK we are moving from policy into practice, using initiatives like AI Airlock to build a more proportionate, lifecycle-based approach.
“These are global technologies, so close collaboration with the FDA and other regulators will be critical to giving innovators greater clarity while maintaining strong protections for patients.”
The MHRA is simultaneously putting new infrastructure behind its relationship with the FDA. The MHRA-FDA Pioneer Programme, announced in June, establishes dedicated reciprocal liaison roles within the two regulators. The programme is designed to deepen day-to-day collaboration, scientific exchange and coordination on emerging regulatory challenges, including medical devices and AI. Both agencies will continue to make independent regulatory decisions.
Excerpt from the official page. The original is authoritative. Continue reading at UK MHRA ↗