MedTech Europe issues position paper on the mandatory use of EUDAMED

In the light of the anticipated go-live of most of the European database on medical devices (EUDAMED) modules in 2025, MedTech Europe has summarised in a position paper its viewpoint on ensuring a smooth transition to its mandatory use, in which it calls for improved accessibility, efficiency and consistency through technical and regulatory measures in the last phase of EUDAMED development, commenting:

“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.”

In the position paper, the association continues:

“MedTech Europe welcomes the gradual implementation of EUDAMED. At the same time, system usability and efficiency issues mean that users need to expend excessive resources due to many manual processes, requests for repetitive data input and missing system optimisations. System usability and efficiency would be achieved by turning the current minimal viable product into an integrated, consistent, state-of-the-art, multi-modular system”.

The full position paper can be accessed from here.