The MHRA is seeking strengthen its ties with the US FDA, as it sets out its next phase of MedTech and AI regulation.
While speaking at the AdvaMed conference in Boston, US on Tuesday (20), Jessica Paulsen, MHRA Deputy Director for AI and Software, outlined her organisation’s approach to software and AI-enabled medical devices, including more flexible lifecycle regulation, regulatory sandboxes and closer international collaboration.
She 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-FDA Pioneer Programme, announced in June, establishes dedicated reciprocal liaison roles within the two regulators.
The MHRA is now recruiting a Regional Deputy Director of US Partnerships, to be based in Washington, who will liaise with the FDA under this programme.
The role is intended to deepen ties with the FDA, strengthen scientific and regulatory collaboration, and build connections between the UK and US life sciences ecosystems.
The programme is designed to deepen day-to-day collaboration, scientific exchange and coordination on emerging regulatory challenges, including medical devices and AI.
However, both agencies will continue to make independent regulatory decisions.
The MHRA is also seeking a wider medical device reform, including improved post-market surveillance and proposed legislative changes to support a more responsive future regulatory framework.
The MHRA 2030 strategy aims to make the regulatory body 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.
The UK Government recently 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.
