From Fragmentation
to Centralization:

End of 2025, the European Commission presented the “Digital Omnibus” to streamline rules on AI, data and cybersecurity and proposed revisions to the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). In addition, stakeholders across the MedTech sector are calling for stronger coordination and clearer responsibility at EU level. The key question now is how to translate the EU commitment to reform into a governance structure that delivers greater efficiency, consistency and accountability.

In the EU, responsibility for medical device regulation is currently distributed across EU institutions, national authorities, notified bodies, industry, and expert groups. As medical technologies are becoming increasingly complex, AI-enabled systems and combined products may fall under several regulatory frameworks at the same time. The researchers argue that this fragmentation of responsibilities leads to inconsistent regulatory decisions, low transparency and (chiefly as a result of low transparency) lack of accountability. Manufacturers face uncertainty about regulatory pathways, evidence requirements and the interpretation of existing rules in different states.

A question of governance: From coordination office to EU medical device agency

The paper examines different models for improved EU level governance, ranging from a coordination office, to a division within an existing agency, to a dedicated EU medical device agency, to a fully centralized federal agency.

The crucial question is not whether to centralize, but how responsibilities, expertise and accountability are organized appropriately and effectively,” explains Anett Schönfelder, first author and researcher in the team of Prof. Stephen Gilbert, Professor of Medical Device Regulatory Science at TUD.

Based on their analysis, the researchers argue that the most effective option would be a dedicated EU-level structure in the most centralized option possible. This could take the form of a new, single central EU governance structure, e.g. European medical device agency or a well-defined division within an existing agency, such as the European Medicines Agency (EMA). This centralized governance structure should be responsible for regulatory strategy, coordination and support. Such a unit would need sufficient legal authority, resources and scientific expertise, as well as a mandate to define and enforce regulatory rules and guidance. This would lead to clearer responsibilities and more consistent decision-making across the EU.

With their perspective, the researchers aim to contribute their scientific expertise to the ongoing discussions on the future of medical device regulation in the EU.

Right now, we have a fragmented system in which responsibilities and decisions are spread across multiple actors without a transparent record. Highly innovative medical technologies need coordinated, evidence-based decisions made by the best available experts. These decisions should follow consistent processes, be transparent to stakeholders and be monitored to ensure the regulatory system is working effectively,” says Prof. Stephen Gilbert.