Commission proposes mandatory use of Eudamed on a roll-out basis

The European Commission has proposed to accelerate the timeline for complying with EUDAMED requirements by making the use of finalized modules mandatory on a gradual basis.

Under the current regulations, EUDAMED will not become mandatory until all six of its modules are in place; however, under the proposed revisions, EUDAMED compliance would be rolled out gradually, “as soon as [the modules] have been audited and declared functional,” comments the Commission.

Three EUDAMED modules have been available to manufacturers for voluntary use since December 2020 and October 2021, but the other modules are not expected to be available until the second quarter of 2024 and the third quarter of 2026.

The Commission notes that EUDAMED is critical to the implementation of MDR and IVDR because it and the competent authorities need the data EUDAMED will gather to monitor potential product shortages in the EU market. Furthermore, it can prevent companies from registering their product multiple times and streamline product information reporting on the national level.

With that in mind, the Commission is proposing to require mandatory adherence to several modules in EUDAMED right after they’ve been audited and found to be functional starting in the fourth quarter of 2025.