Regulatory Science: A Condition of Innovation for AI as a Medical Device

AI systems are increasingly being introduced into healthcare, many of them meeting the threshold for regulation as medical devices. However, the regulatory frameworks built to evaluate their safety and performance were designed for stable, tangible products rather than the highly context-dependent, frequently updating software systems whose risks emerge in real-world use. This creates a dilemma for health systems: the pressure to adopt AI at pace sits uneasily alongside the need to validate, monitor, and govern it vigilantly. This piece will describe how regulatory science offers a route through this tension to realise the benefits of innovation safely. Drawing on national infrastructure and case studies from the Centre of Excellence for Regulatory Science and Innovation in AI and Digital Health (CERSI-AI), this article sets out what regulatory science looks like in practice, and why building the governance and capability to deploy AI responsibly may prove harder than building the technology itself.