EC: Q&As on Gradual Roll Out of EUDAMED
The European Commission (EC) has published a Q&A on practical aspects related to the implementation of the gradual roll-out of Eudamed pursuant to the MDR and IVDR, as amended by Regulation (EU) 2024/1860 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices.
There are a total of 20 questions and answers relating to the phased introduction and transition periods for mandatory use of each module.
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