Speaking on Tuesday 20 October, Jessica Paulsen, MHRA Deputy Director for AI and Software, will discuss the UK regulator's evolving approach to software and AI-enabled medical devices. Key elements include more flexible lifecycle regulation, the use of regulatory sandboxes, and enhanced international collaboration.
This presentation follows the publication of the MHRA 2030 Strategy, which aims to modernise regulation for an era of AI and personalised medicine. For MedTech, the strategy includes developing an 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 international regulators like the FDA.
The MHRA 2030 strategy sets a global standard ambition for the safe and agile regulation of MedTech and AI by 2030, aiming to accelerate access to innovative technologies while ensuring patient safety. This month, the UK Government endorsed all 44 recommendations from an independent commission on AI regulation in healthcare, supporting a more proportionate, lifecycle-based approach.
The MHRA is currently testing this approach through its AI Airlock, a regulatory sandbox for AI-enabled medical devices. This initiative is supported by regional partnerships with organisations such as NHS London and Manchester University NHS Foundation Trust, utilising the UK's healthcare system and academic expertise to test innovations in real-world health settings.
“"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 also strengthening its relationship with the FDA through the MHRA-FDA Pioneer Programme, announced in June. This programme establishes dedicated liaison roles within both regulators to deepen collaboration, scientific exchange, and coordination on emerging challenges, including medical devices and AI. Both agencies will continue to make independent regulatory decisions.
This initiative builds on existing UK-US work, with the MHRA having previously outlined ambitions to strengthen regulatory alignment, reduce transatlantic market access barriers, and explore greater use of international reliance routes. The agency is currently recruiting a Regional Deputy Director of US Partnerships, based in Washington, D.C., to serve as the dedicated Liaison Officer to the FDA.
Alongside AI and international collaboration, the MHRA is advancing broader medical device reform, including enhanced post-market surveillance and proposed legislative changes for a more responsive regulatory framework. Further details are available in the MHRA 2030 Strategy announcement, the National Commission into the Regulation of AI in Healthcare, and announcements regarding the London and Manchester health innovation sandbox and wider regulatory reform.
