During the conference held on Tuesday, 20 October, Jessica Paulsen, the Deputy Director for AI and Software at the MHRA, will discuss the evolving regulatory landscape for software and AI-enabled medical devices in the UK. Her address will focus on initiatives such as more flexible lifecycle regulation, the introduction of regulatory sandboxes, and enhanced international collaboration.
Paulsen’s speech follows the release of the MHRA 2030 Strategy, which outlines the regulator’s plans to modernise the framework governing AI and personalised medicine. Key objectives for the MedTech sector include the establishment of a contemporary and adaptive regulatory framework for AI as a medical device, the creation of a new MHRA Centre for AI and Digital Health, improvements in device data and traceability, and the expansion of reliance and recognition routes in partnership with trusted international regulators, including the FDA.
A Vision for Modern Regulation
The MHRA 2030 Strategy aims to position the agency as a leader in providing a global standard for safe and agile regulation of MedTech and AI by the year 2030. The strategy seeks to facilitate quicker access to innovative technologies while simultaneously enhancing patient safety. Earlier this month, the UK Government endorsed all 44 recommendations proposed by the NHS doctor-led independent National Commission into the Regulation of AI in Healthcare, advocating for a more balanced, lifecycle-oriented approach to AI regulation.
The MHRA is already putting this strategy into practice through its AI Airlock initiative, a regulatory sandbox designed for AI-enabled medical devices. This effort is further supported by new regional partnerships with organisations such as NHS London and the Manchester University NHS Foundation Trust. These collaborations aim to leverage the unique strengths of the UK’s healthcare system and academic capabilities to trial innovative technologies in real-world health environments, generating vital evidence to shape future regulatory frameworks.
Embracing Collaboration and Innovation
This combined effort will enable the MHRA to devise regulations that can adapt to the evolving nature of AI-enabled devices while providing developers with clearer guidance on regulatory expectations. Paulsen remarked, “AI is transforming medical technology, and regulation must evolve accordingly. In the UK, we are transitioning from policy to practice, employing initiatives like AI Airlock to foster a more proportional, lifecycle-based regulatory approach.”
She added, “Given that these are global technologies, collaboration with the FDA and other regulatory bodies is essential to provide innovators with clearer pathways while ensuring robust patient protections.”
Strengthening Transatlantic Ties
In tandem with these developments, the MHRA is enhancing its collaboration with the FDA through the newly established MHRA-FDA Pioneer Programme. Announced in June, this initiative creates dedicated reciprocal liaison roles within both regulatory bodies, aimed at improving daily collaboration, scientific exchange, and coordination on emerging regulatory challenges concerning medical devices and AI. Importantly, both agencies will continue to make independent regulatory decisions.
This initiative builds on existing UK-US collaborations in the fields of medical technology and AI. During the 2025 AdvaMed conference, the MHRA expressed its commitment to strengthening regulatory alignment and reciprocity with the FDA, minimising transatlantic barriers to market access, and exploring greater use of international reliance routes, particularly for devices already approved by the FDA.
New Leadership for US Partnerships
The MHRA is currently seeking a Regional Deputy Director of US Partnerships, based in Washington, D.C. This individual will act as the MHRA’s dedicated Liaison Officer to the FDA under the Pioneer Programme. This senior role aims to deepen the MHRA’s relationship with the FDA, foster scientific and regulatory collaboration, and create connections between the life sciences sectors in the UK and the US.
This appointment is part of the broader ambition of the MHRA not only to maintain a presence in the US but to cultivate relationships that benefit patients, drive innovation, and enhance the UK’s standing in the global life sciences arena.
Advancing Medical Device Reform
In addition to its focus on AI and international partnerships, the MHRA is actively pursuing broader reforms in medical device regulation. This includes enhancements to post-market surveillance and proposed legislative changes aimed at creating a more responsive regulatory framework for the future.
The overall direction of these initiatives is encapsulated in the MHRA 2030 Strategy announcement, which aligns with recent actions taken in response to the National Commission into the Regulation of AI in Healthcare, details regarding the London and Manchester health innovation sandbox, and various regulatory reform announcements made by the UK regulator.
About the MHRA
The MHRA is tasked with regulating all medicines and medical devices within the UK, ensuring their efficacy and safety. It operates as an executive agency of the Department of Health and Social Care.
For media inquiries, please contact newscentre@mhra.gov.uk or call 020 3080 7651.
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