UK's Medicines and Healthcare products Regulatory Agency (MHRA)
sets out its next phase of MedTech and AI regulation to US
industry leaders at AdvaMed 2026.
Speaking at the conference on Tuesday 20 October, Jessica
Paulsen, MHRA Deputy Director for AI and Software, will outline
the UK regulator's developing approach to software and AI-enabled
medical devices, including more flexible lifecycle regulation,
regulatory sandboxes and closer international
collaboration.
She is speaking on following the publication of the MHRA
2030 Strategy, which sets out plans to modernise regulation for
an era of AI and personalised medicine. For MedTech, this
includes creating a modern, adaptive framework for AI as a
medical device, establishing a new MHRA Centre for AI and Digital
Health, improving device data and traceability, and expanding
reliance and recognition routes with trusted international
regulators, including the FDA.
The MHRA 2030 strategy sets an ambition for the MHRA to deliver a
global standard for safe and agile regulation of MedTech and AI
by 2030, supporting faster access to innovative technologies
while strengthening patient safety. This month, the UK
Government accepted all 44 recommendations of the NHS doctor-led
independent National Commission into the Regulation of AI in
Healthcare, supporting a more proportionate, lifecycle-based
approach to AI regulation.
The MHRA is already testing this approach through its AI Airlock,
its regulatory sandbox for AI-enabled medical devices. It is
complemented by a series of new regional partnerships including
with NHS London and Manchester University NHS Foundation Trust,
leveraging the UK's unique healthcare system and academic
excellence to test innovative technologies in real health
settings and generate evidence to inform future regulatory
approaches.
Together, this work will help the MHRA develop regulation that
can respond to AI-enabled devices that evolve throughout their
lifecycle, while giving developers greater clarity on regulatory
requirements.
Jessica Paulsen, MHRA Deputy Director for AI and
Software, said:
AI is changing medical technology, and regulation must keep pace.
In the UK we are moving from policy into practice, using
initiatives like AI Airlock to build a more proportionate,
lifecycle-based approach.
These are global technologies, so close collaboration with the
FDA and other regulators will be critical to giving innovators
greater clarity while maintaining strong protections for
patients.
The MHRA is simultaneously putting new infrastructure behind its
relationship with the FDA. The MHRA-FDA Pioneer Programme,
announced in June, establishes dedicated reciprocal liaison roles
within the two regulators. The programme is designed to deepen
day-to-day collaboration, scientific exchange and coordination on
emerging regulatory challenges, including medical devices and AI.
Both agencies will continue to make independent regulatory
decisions.
The initiative builds on existing UK-US work on medical
technology and AI. At AdvaMed in 2025, the MHRA set out ambitions
to strengthen regulatory alignment and reciprocity with the FDA,
reduce transatlantic barriers to market access and explore
greater use of international reliance routes, including for
devices already approved by the FDA.
The MHRA is now recruiting a Regional Deputy Director of US
Partnerships, based in Washington, D.C., who will serve as the
MHRA's dedicated Liaison Officer to the FDA under the Pioneer
Programme. The senior role is intended to deepen the relationship
with the FDA, strengthen scientific and regulatory collaboration,
and build connections between the UK and US life sciences
ecosystems.
The appointment forms part of a wider MHRA ambition not simply to
maintain a US presence, but to build relationships that deliver
for patients, innovation and the UK's position in global life
sciences.
Alongside AI and international collaboration, the MHRA is
progressing wider medical device reform, including improved
post-market surveillance and proposed legislative changes to
support a more responsive future regulatory framework.
The overall direction is set out in the MHRA 2030 Strategy
announcement, alongside recent action on the National Commission into
the Regulation of AI in Healthcare, details on the London and
Manchester health
innovation sandbox and wider regulatory
reform announcements made recently by the UK regulator.
