Q&A on gradual roll-out of EUDAMED

The European Commission 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.

This document consists of 3 parts:

• EUDAMED gradual roll-out (Article 34 MDR)
• EUDAMED’s transition periods for mandatory use (Articles 123 MDR and 113 IVDR)
• Transition periods per EUDAMED module

DOWNLOAD THE Q&A