TL;DR

The MHRA, the UK’s medicines and devices regulator, is using the US medtech conference AdvaMed 2026 to set out how it plans to regulate AI-enabled medical devices. Jessica Paulsen, the deputy director responsible for its AI and software work, speaks on Tuesday 20 October. Alongside the talk, the MHRA is recruiting a senior officer in Washington DC to act as its dedicated liaison with the US Food and Drug Administration (FDA).

The message to US industry

Paulsen’s talk covers three themes: more flexible regulation that covers a device across its whole lifecycle, regulatory sandboxes, and closer work with other regulators. “In the UK we are moving from policy into practice,” she said, pointing to the AI Airlock, the MHRA’s sandbox for AI medical devices. The agency is also testing technologies in real settings through regional partnerships with Manchester University NHS Foundation Trust and NHS London.

The pitch builds on two recent UK moves. The regulator’s 2030 Strategy, which we covered when it launched, promises adaptable rules covering AI as a medical device and an AI and digital health centre inside the agency. And this month the government accepted all 44 recommendations of the doctor-led national commission on regulating AI in healthcare, which backs a proportionate, lifecycle-based approach.

A new post near the FDA

The new detail is staffing. The MHRA and FDA unveiled a Pioneer Programme in June, under which the two regulators are creating reciprocal liaison roles to deepen day-to-day cooperation on emerging issues, including AI and devices. The MHRA’s side of that is a new Washington-based regional deputy director post covering US partnerships, whose holder will be its dedicated contact at the FDA. The agency stresses that both regulators will keep making independent decisions.

A year earlier, at the 2025 AdvaMed, the agency outlined goals to reduce transatlantic barriers and lean more on reliance routes, for example for products already cleared by the FDA. “These are global technologies,” Paulsen said, so collaboration with the FDA “will be critical”.

Looking forward

The announcement is a preview of what Paulsen will say, so the substance of the talk itself is not yet public. For UK developers of AI health software, the useful signal is direction: the MHRA wants rules that let products change after approval, and closer links with the FDA. In our view, if the reliance routes widen, a device cleared in one market could reach the other faster, which matters for small UK firms that cannot afford two full approval processes.