MHRA recruits Washington-based FDA liaison as it presents AI device plans at AdvaMed

The MHRA is hiring a senior official in Washington, D.C. to act as its dedicated liaison officer to the FDA, it said on 19 October 2026, as it prepared to present its plans for AI and software medical devices to US industry at AdvaMed 2026¹. Jessica Paulsen, the agency's Deputy Director for AI and Software, speaks at the conference on Tuesday 20 October¹.

What the MHRA set out

The new post, Regional Deputy Director of US Partnerships, sits under the MHRA-FDA Pioneer Programme announced in June. That programme creates reciprocal liaison roles inside both regulators to support routine collaboration and scientific exchange on emerging issues, devices and AI among them. The MHRA stresses that each agency keeps making its own regulatory decisions¹.

Paulsen's speech covers lifecycle regulation for AI-enabled devices, regulatory sandboxes and wider international collaboration. It follows the MHRA 2030 Strategy, which commits the agency to an adaptive framework for AI as a medical device, a new MHRA Centre for AI and Digital Health, better device data and traceability, and more reliance and recognition routes with trusted overseas regulators, the FDA included¹. "AI is changing medical technology, and regulation must keep pace," Paulsen said¹.

The domestic rulebook is moving on a set timetable. Earlier in October the MHRA adopted all 44 recommendations of the National Commission into the Regulation of AI in Healthcare, an independent group led by NHS doctors¹². The central recommendation is that AI-enabled devices should be monitored for as long as they are in use, because a single assessment before market entry cannot capture products that change over time and perform differently across settings and workflows². The MHRA plans draft guidance by December on handling changes to adaptive AI devices, a consultation at the start of next year on how such devices are qualified and classified, and a full implementation roadmap for the 44 recommendations by spring 2027².

Testing runs through AI Airlock, the agency's sandbox for AI-enabled devices, whose next cohort will concentrate on post-market surveillance and lifecycle regulation, with first selections in November². The MHRA has also set up regional partnerships with NHS London and Manchester University NHS Foundation Trust to trial technologies in live NHS settings and gather evidence for future rules¹.

What it means for the market

For AI device makers selling into the NHS, the direction is towards lighter-touch entry paired with ongoing obligations once a product is deployed. Suppliers should expect post-market surveillance, rather than a one-off approval, to carry more of the regulatory weight². NHS trusts and ICBs buying AI tools may in turn find more of the evidence burden sitting in live deployment, as the London and Manchester partnerships suggest¹.

The FDA liaison role matters most to companies selling on both sides of the Atlantic. At AdvaMed in 2025 the MHRA said it wanted closer alignment and reciprocity with the FDA, fewer barriers to market access and more use of international reliance routes, including for devices the FDA has already approved¹. A permanent liaison in Washington gives that aim staff and a fixed point of contact. MedTech Dive notes that the FDA is also weighing post-market monitoring as an approach for AI devices², which could ease alignment, though neither source says the two regulators will adopt common requirements.

Caveats

The 19 October release previews a conference speech and restates plans already announced. It sets no date for the liaison appointment and gives no detail on which FDA-cleared devices could reach the UK market through reliance routes¹. Wider device reform, including better post-market surveillance and proposed legislative changes, is still in progress¹. The next fixed point is the MHRA's draft guidance on changes to adaptive AI devices, due by December².