The UK Medicines and Healthcare products Regulatory Agency (MHRA) set out its next phase of MedTech and AI regulation to US industry leaders at AdvaMed 2026, according to a release published on 19 October 2026. Jessica Paulsen, MHRA Deputy Director for AI and Software, was scheduled to speak at the conference on Tuesday 20 October, outlining a developing approach that includes more flexible lifecycle regulation, regulatory sandboxes and closer international collaboration.

The release followed publication of the MHRA 2030 Strategy, which sets an ambition to deliver a global standard for safe and agile regulation of MedTech and AI by 2030. Planned measures include a framework for AI as a medical device, a new MHRA Centre for AI and Digital Health, improved device data and traceability, and expanded reliance and recognition routes with trusted international regulators including the FDA. The MHRA said it is testing the approach through its AI Airlock sandbox and new regional partnerships.

The agency also cited the MHRA-FDA Pioneer Programme, announced in June 2026, establishing reciprocal liaison roles while both agencies continue to make independent regulatory decisions. The MHRA said it was recruiting a Regional Deputy Director of US Partnerships, based in Washington, D.C., to serve as its dedicated Liaison Officer to the FDA.