Readability & Display

Reviewed guidance topic

EUDAMED

Registration and operational use of the European Database on Medical Devices.

Official catalogue · non-binding

EUDAMED guidance (7)

Catalogue entries are ordered as they appear in the European Commission catalogue.

Browse topics
MDCG 2024-15Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMEDNovember 2024
MDCG 2026-4MDCG Position Paper: Management of SS(C)P in EUDAMED after mandatory useJune 2026
Gradual roll out of EUDAMEDQ&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 devices1November 2024
MDCG 2022-12Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices)July 2022
MDCG 2021-13 rev.1Questions 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 IVDRJuly 2021
MDCG 2021-1 rev.1Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functionalMay 2021
Guidance documentThe EMDN – The nomenclature of use in EUDAMEDJanuary 2020