The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is outlining its evolving strategy for software and AI-enabled medical devices at the AdvaMed 2026 conference. Jessica Paulsen, MHRA Deputy Director for AI and Software, is scheduled to detail plans for more flexible lifecycle regulation, regulatory sandboxes, and closer international collaboration on Tuesday, 20 October.
This initiative follows the publication of the MHRA 2030 Strategy, which seeks to modernise regulation for AI and personalised medicine. Key aspects for MedTech include creating an adaptive framework for AI as a medical device, establishing a new MHRA Centre for AI and Digital Health, and enhancing device data and traceability. The strategy also aims to expand reliance and recognition routes with international regulators, such as the FDA.
The MHRA is already implementing this approach through its AI Airlock, a regulatory sandbox for AI-enabled medical devices. This is supported by new regional partnerships, including with NHS London and Manchester University NHS Foundation Trust, to test innovative technologies in real healthcare settings. The MHRA is also strengthening its relationship with the FDA through the MHRA-FDA Pioneer Programme, announced in June, which establishes dedicated liaison roles to deepen collaboration and scientific exchange.
Jessica Paulsen stated that regulation must keep pace with AI's impact on medical technology. She added that close collaboration with the FDA and other regulators is crucial for innovators while maintaining strong patient protections.