From Regulation to Practice: Translational Regulatory Science for Patient-Centred Health Technologies

Health technologies are governed by comprehensive European regulatory frameworks, yet clear, evidence-driven methodologies translating these requirements into real-world, patient-centred practice remain limited—particularly for digital and AI-enabled innovations. This gap constrains regulatory decision-making, slows uptake, and creates uncertainty for developers, clinicians, and patients.

We contribute to translational regulatory science by developing and refining practical, evidence-based methodologies that bridge regulatory requirements and real-world implementation across the health technology lifecycle. Our work focuses on interpreting existing frameworks (e.g. MDR, IVDR, AI Act) and transforming them into actionable guidance, evaluation approaches, and design processes that support regulatory assessment of safety, performance, usability, and trust.

Through end-user-driven and participatory approaches, we integrate patient and clinician perspectives with regulatory and technical constraints, addressing gaps in evidence generation, explainability, and real-world relevance—particularly for AI and digital health technologies. We employ mixed qualitative and quantitative methods and leverage existing clinical and real-world data to support evidence-informed decision-making without conducting clinical studies.

Our outputs aim to provide actionable tools, methods, and guidance for regulators, policymakers, and innovators, facilitating the timely uptake of safe, effective, and patient-centred health technologies into clinical workflows and health systems, while maintaining high standards of evidence and patient safety.