In the light of the anticipated go-live of most European database on medical devices (EUDAMED) modules in 2025, MedTech Europe summarises in a position paper the industry viewpoints on the smooth transition to the mandatory use of the European database for medical devices. MedTech Europe ambition is to call for improved accessibility, efficiency and consistency through technical and regulatory measures in the last phase of EUDAMED development.
EUDAMED is a fundamental infrastructure of IVDR and MDR. The successful implementation of EUDAMED requires addressing usability challenges, ensuring adequate support for users, and creating a transition approach with reliable timelines.
Industry readiness and the efficient use of resources will be vital in transitioning to the use of the central database.
Smooth transition to the mandatory use of EUDAMED – Perspectives from manufacturers