MedTech Europe and industry partners call for stronger future governance of medical technologies

Posted on 03.04.2025

MedTech Europe, in collaboration with key EU trade associations AESGP, COCIR, EEAR, EUROM, and FIDE, has published a joint discussion paper advocating for a reform of the European regulatory system for medical devices and in vitro diagnostic medical devices. The paper builds on MedTech Europe’s 2023 position paper on the Future of the regulatory system from 2023. It emphasises the need to first define the roles and responsibilities of a future single governance structure for medical technologies before exploring specific governance models. It aims to provide a clear roadmap for regulatory improvements that will ensure a more effective and predictable system for the sector.

This discussion paper is meant to facilitate and stimulate exchanges with all involved stakeholders as part of the reforms needed to the Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation following the completion of the European Commission Targeted Evaluation.

For more information, please contact Jana Russo, Manager Medical Devices.