Advancing Regulation for AI-Enabled Medical Devices
During a conference on Tuesday, 20 October, Jessica Paulsen, the Deputy Director for AI and Software at the MHRA, is set to discuss the evolving regulatory landscape for software and AI-enabled medical devices in the UK. Her presentation will delve into the regulator’s progressive approach, which includes the implementation of flexible lifecycle regulations, the introduction of regulatory sandboxes, and enhanced international collaboration.
This talk follows the release of the MHRA’s 2030 Strategy, a comprehensive framework aimed at modernising regulations in line with advancements in AI and personalised medicine. The strategy outlines plans for a modern, adaptive regulatory framework specifically for AI as a medical device, the establishment of a new MHRA Centre for AI and Digital Health, and improvements in device data management and traceability. Additionally, it aims to expand reliance and recognition pathways in partnership with trusted international regulators, notably the FDA.
Setting High Standards for MedTech Regulation
The MHRA 2030 Strategy aspires to establish a global benchmark for safe and agile regulation of medical technologies and AI by the year 2030. This initiative is designed to facilitate quicker access to innovative technologies while simultaneously bolstering patient safety. Recently, the UK Government endorsed all 44 recommendations from the NHS doctor-led independent National Commission examining AI regulation in healthcare, advocating for a more proportionate, lifecycle-oriented regulatory framework.
The MHRA is actively trialling this innovative regulatory approach through its AI Airlock initiative, which serves as a regulatory sandbox for AI-enabled medical devices. This effort is further enhanced by new regional partnerships with organisations such as NHS London and Manchester University NHS Foundation Trust, capitalising on the UK’s distinctive healthcare infrastructure and academic prowess to evaluate novel technologies within actual health environments, thereby generating vital evidence for future regulatory strategies.
Building International Collaboration for Innovation
Jessica Paulsen emphasised the necessity of aligning regulation with the rapid advancements in medical technology, stating, “AI is transforming medical technology, and regulation must keep pace. In the UK, we are transitioning from policy to practice by utilising initiatives like AI Airlock to foster a more balanced, lifecycle-focused regulatory approach.”
She also highlighted the importance of global collaboration, noting that close cooperation with the FDA and other regulatory bodies is essential for providing innovators with clear guidance while ensuring robust protections for patients.
In tandem with these efforts, the MHRA is enhancing its relationship with the FDA through the newly established MHRA-FDA Pioneer Programme. Launched in June, this programme creates specific reciprocal liaison roles within both regulatory bodies, designed to foster daily collaboration, scientific exchange, and coordinated responses to emerging regulatory challenges, particularly in the realm of medical devices and AI. Both the MHRA and FDA will continue to maintain their independence in regulatory decision-making.
Strengthening US Partnerships and Future Initiatives
This initiative builds on the existing UK-US collaborations in medical technology and AI. At the AdvaMed conference in 2025, the MHRA articulated its ambitions to enhance regulatory alignment with the FDA, minimise transatlantic barriers to market entry, and explore increased utilisation of international reliance routes for devices already sanctioned by the FDA.
To further these goals, the MHRA is currently in the process of appointing a Regional Deputy Director of US Partnerships, who will be stationed in Washington, D.C. This role is designated to serve as the MHRA’s liaison to the FDA under the Pioneer Programme, facilitating deeper engagement with the FDA, enhancing scientific and regulatory collaboration, and fostering connections between the life sciences sectors of the UK and the US.
Broader Initiatives for Medical Device Reform
This appointment is part of the MHRA’s broader vision not just to maintain a presence in the US but to cultivate relationships that ultimately benefit patients, stimulate innovation, and reinforce the UK’s standing in the global life sciences arena.
In addition to focusing on AI and international cooperation, the MHRA is advancing comprehensive reforms in medical device regulation, which include enhanced post-market surveillance and proposed legislative adjustments to create a more responsive regulatory framework for the future. The overarching direction of these initiatives is outlined in the MHRA 2030 Strategy, alongside recent actions taken in response to the National Commission’s recommendations regarding AI regulation in healthcare, and details regarding the health innovation sandbox initiatives in London and Manchester.
About the MHRA
The MHRA is tasked with overseeing the regulation of all medicines and medical devices in the UK, ensuring their efficacy and safety. As an executive agency of the Department of Health and Social Care, the MHRA plays a crucial role in safeguarding public health.
For media inquiries, please reach out to newscentre@mhra.gov.uk or contact 020 3080 7651.