MHRA Signals Closer FDA Ties as UK Shapes Rules for AI Medical Devices

The UK medicines and medical devices regulator is using the AdvaMed 2026 conference to signal a more flexible approach to AI-enabled medical devices and closer working ties with the US Food and Drug Administration. Jessica Paulsen, the MHRA deputy director responsible for AI and software, is scheduled to speak on Tuesday, October 20; the account of her remarks is a preview, not a report of what she ultimately said.

The MHRA’s stated priorities include regulation that can account for a device throughout its lifecycle, regulatory sandboxes and greater cooperation among regulators. Paulsen pointed to the agency’s AI Airlock, a sandbox for AI medical devices, and to testing in real-world settings through partnerships with Manchester University NHS Foundation Trust and NHS London.

The agency is also recruiting a senior officer in Washington, DC, to serve as regional deputy director for US partnerships and its dedicated contact at the FDA. The post is part of a reciprocal liaison effort under the Pioneer Programme, announced by the two regulators in June. The MHRA says the arrangement is intended to deepen day-to-day cooperation on emerging issues, while leaving each regulator responsible for its own decisions.

The push follows the MHRA’s 2030 Strategy, which calls for adaptable rules for AI as a medical device and an AI and digital health centre within the agency. The UK government has also accepted all 44 recommendations from a doctor-led national commission on regulating AI in healthcare, according to the report; the recommendations support a proportionate, lifecycle-based approach.

At AdvaMed in 2025, the MHRA had already described ambitions to reduce transatlantic barriers and make greater use of reliance routes, such as pathways for products already cleared by the FDA. Whether those routes will expand remains uncertain. If they do, the report suggests, they could help some devices move between markets more quickly—but the agency has not announced any specific change to approvals.