Researchers from EKFZ at TU Dresden urge Europe to create CERSIs; to accelerate regulatory science for medical AI

Researchers from EKFZ at TU Dresden urge Europe to create CERSIs; to accelerate regulatory science for medical AI

Europe needs stronger regulatory science for medical AI and MedTech - Else Kröner Fresenius Center for Digital Health

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Europe needs stronger regulatory science for medical AI and MedTech

In a new comment published in the journal “Nature Biomedical Engineering”, researchers from the Else Kröner Fresenius Center (EKFZ) for Digital Health at TUD Dresden University of Technology, in collaboration with international researchers, argue that Europe should establish Centres of Excellence in Regulatory Science and Innovation (CERSIs). These academic-led centres could help ensure that regulation keeps pace with rapidly developing medical technologies and artificial intelligence.

A Schönfelder, AK Denniston, AF Frangi, C Johner, T Minssen, K Singh, S Gilbert: European Union Innovation needs Regulatory Science Excellence Centres , Nature Biomedical Engineering, 2026, doi: 10.1038

Researchers identify structural weaknesses in European regulation

Medical AI and advanced medical devices are developing faster than traditional regulatory processes were designed to handle. Many of today’s technologies no longer fit neatly into fixed categories: AI tools adapt over time, work across different clinical settings, or combine several functions that were previously performed by separate devices. The traditional regulation of products for a single intended purpose is becoming increasingly outdated. This creates a regulatory challenge for medical innovation: Regulation must ensure that medical technologies are safe and effective for patients. At the same time, it must be able to support responsible innovation. In a new publication, the international team of authors argues that Europe’s current regulatory system is too fragmented to meet this challenge. Responsibilities are distributed across multiple actors, including the European Commission, the Medical Device Coordination Group, national competent authorities, notified bodies and expert panels. According to the authors, the absence of a central structure responsible for regulatory strategy can make assessment pathways difficult to predict and slow to adapt, particularly for AI-enabled medical devices. Also, research on new regulatory methods, evidence standards, and emerging risks is not yet coordinated at the scale needed. As a result, innovators may face unclear pathways, regulators may lack timely scientific input, and patients may wait longer for safe and useful technologies.

First author of the publication and researcher in the team of Prof. Stephen Gilbert

What we need is a stronger scientific basis for regulation of medical devices: independent centers that can identify emerging risks early, develop evidence-based methods, and help Europe respond proactively to technological change.”

A practical model for future-ready regulation

The authors propose establishing European “Centres of Excellence in Regulatory Science and Innovation” (CERSIs). These centres would not replace regulators or make binding decisions. Instead, they could provide independent expertise, generate evidence early, monitor emerging developments, offer training, and develop practical tools to support better regulatory decisions for medical AI, digital health technologies, medical devices, and in vitro diagnostics.

The authors argue that Europe can learn from the United States, where the U.S. Food and Drug Administration established CERSIs more than a decade ago, and from the United Kingdom, which recently launched its own CERSI program. These centres bring together regulators, academic researchers, industry and other stakeholders to work on priority questions in regulatory science. Their work can include developing new evaluation methods, supporting guidance documents, improving post-market surveillance, and identifying emerging challenges such as generative AI in diagnostics, synthetic data or continuous monitoring tools.

Professor of Medical Device Regulatory Science

Regulation must ensure patient safety without slowing down responsible innovation. To achieve this, Europe needs sustained scientific capacity in regulatory science rather than relying only on individual projects or short-term consultations. European Centres of Excellence in Regulatory Science and Innovation would connect academic expertise, regulatory needs, and technological development. They would provide the research capacity and long-term knowledge base needed to make medical AI and MedTech regulation more adaptive, predictable, and fit for purpose.”

To have a practical impact, European CERSIs would need clearly defined links to EU institutions and regulatory processes. Otherwise, their findings might remain scientifically valuable without being translated into guidance and regulatory practice. The centres would not resolve all structural challenges in European medical-device regulation, the authors acknowledge. However, they would provide an important scientific foundation for regulation that protects patients while enabling responsible innovation.

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