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.