Orientations réglementaires
Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices)
Publié 1 juil. 2022
Référence
MDCG 2022-12
Source
MDCG
Thème
EUDAMED
Publié
1 juil. 2022
Langues
EN
© European Union — European Commission, DG SANTE. Reuse under CC BY 4.0.
MDCG Position Paper: Management of SS(C)P in EUDAMED after mandatory use
Publié 1 juin 2026
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 amending Regulations (EU) 2017/745 and (EU) 2017/746 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 devices1
Publié 1 nov. 2024
Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR
Publié 1 juil. 2021
Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional
Publié 1 mai 2021