MHRA advances MedTech and AI regulatory agenda with U.S. industry outreach

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MHRA advances MedTech and AI agenda

Highlights

MHRA 2030 Strategy aims to establish a global standard for agile MedTech and AI regulation, including a modern adaptive framework and expanded reliance with regulators like the FDA.
MHRA-FDA Pioneer Programme, announced in June, introduces reciprocal liaison roles to deepen U.S.-UK scientific exchange and lower transatlantic barriers for AI-enabled medical devices.
MHRA is advancing practical reforms such as regulatory sandboxes, improved post-market surveillance, and is recruiting a Washington, D.C. liaison to strengthen U.S. partnerships and accelerate innovation access.

UK strategy and regulatory tools

As reported by GOV.UK, Jessica Paulsen, the MHRA's deputy director for AI and software, is telling AdvaMed 2026 on Tuesday 20 October about the regulator's next phase for software and AI-enabled medical devices, including more flexible lifecycle regulation, regulatory sandboxes and closer international collaboration.

Her appearance follows publication of the MHRA 2030 Strategy, which sets out plans to modernise regulation for AI and personalised medicine. For MedTech, the strategy includes a modern adaptive 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 regulators including the FDA.

The strategy sets an ambition for the agency to deliver a global standard for safe and agile MedTech and AI regulation by 2030, with the aim of supporting faster access to innovative technologies while strengthening patient safety. This month, the UK government also accepted all 44 recommendations from the independent National Commission into the Regulation of AI in Healthcare, backing a more proportionate, lifecycle-based model.

The MHRA is already testing that approach through AI Airlock, its regulatory sandbox for AI-enabled medical devices. It is also extending regional partnerships, including with NHS London and Manchester University NHS Foundation Trust, to test technologies in real healthcare settings and generate evidence for future regulatory design.

U.S. ties and life sciences impact

The agency is also putting new infrastructure behind its relationship with the FDA through the MHRA-FDA Pioneer Programme, announced in June. The programme creates reciprocal liaison roles in the two regulators to deepen day-to-day collaboration, scientific exchange and coordination on emerging regulatory issues, including medical devices and AI, while leaving each side to make independent decisions.

The latest step builds on work outlined at AdvaMed in 2025, when the MHRA said it wanted stronger regulatory alignment and reciprocity with the FDA, lower transatlantic barriers to market access and wider use of international reliance routes, including for devices already approved by the U.S. regulator.

The MHRA is now recruiting a regional deputy director of U.S. partnerships based in Washington, D.C., who will serve as its liaison officer to the FDA under the Pioneer Programme. The post is intended to deepen scientific and regulatory collaboration, strengthen links between the UK and U.S. life sciences ecosystems, and support a broader ambition to turn the agency's U.S. presence into practical gains for patients, innovation and the UK's global life sciences position.

Alongside AI and international cooperation, the MHRA is also progressing broader medical device reforms, including stronger post-market surveillance and proposed legislative changes for a more responsive future regulatory framework.

Our earlier report on the Bank of England’s call for “bare metal” recovery planning explained how UK regulators are pushing banks to strengthen operational resilience as AI increases the scale and complexity of cyber threats. It highlighted supervisory pressure for independent fallback systems to keep critical services running if primary technology is compromised, reflecting wider concern that AI could amplify systemic risk in key infrastructure.

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