In this joint discussion paper, the European medical technology industry, represented by MedTech
Europe, AESGP, COCIR, EEAR, EUROM and FIDE, makes the case for a reform of the European
regulatory system for medical devices (MDs) and in vitro diagnostic medical devices (IVDs).
The paper highlights shortcomings in the current multilayered governance system, which affect the
efficiency of the CE marking process, leading to delays in device availability for patients and
healthcare systems as well as challenges to the competitiveness of the medical technology sector
in Europe.
To address these issues, the paper proposes centralising key tasks and describes
specific roles and responsibilities for a future centralised governance structure aimed at improving
efficiency and effectiveness.
The document emphasizes the importance of first establishing the key guiding principles,
determining the appropriate level of empowerment, and defining the roles and responsibilities that
a central structure should assume.
Once these foundational elements are in place, a detailed impact
assessment can be carried out to define the optimal setup and functioning of the central structure.
This discussion paper is meant to facilitate and stimulate exchanges with all involved stakeholders.