EUDAMED Archive - MDCG Helpdesk

Gradual roll out of EUDAMED – 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 devices

Gradual roll out of EUDAMED Rev.0 Q&A on practical aspects related to the implementation of the gradual roll-out of Eudamed pursuant to the MDR and

Januar 20, 2025

MDCG 2021-13 rev.1 – 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

MDCG 2021-13 Rev.1 Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers

Januar 20, 2025

MDCG 2021-1 rev.1 – Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional

MDCG 2021-1 Rev.1 Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional Disclaimer: This document is an interactive version of

Januar 20, 2025

MDCG 2019-5 – Registration of legacy devices in EUDAMED

MDCG 2019-5 Rev.0 Registration of legacy devices in EUDAMED Disclaimer: This document is an interactive version of the original MDCG document. We will keep it

Januar 20, 2025

MDCG 2019-4 – Timelines for registration of device data elements in EUDAMED

MDCG 2019-4 Rev.0 Timelines for registration of device data elements in EUDAMED Disclaimer: This document is an interactive version of the original MDCG document. We

Januar 20, 2025

MDCG 2021-13 rev.1 – 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

MDCG 2021-13 Rev.1 Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers

Januar 20, 2025

MDCG 2021-1 rev.1 – Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional

MDCG 2021-1 Rev.1 Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional Disclaimer: This document is an interactive version of

Januar 20, 2025

MDCG 2022-12 – 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)

MDCG 2022-12 Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical

Januar 20, 2025

MDCG 2020-15 – MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States

MDCG 2021-15 MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States

Januar 15, 2025

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MDCG 2021-13 rev.1 – 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

MDCG 2021-1 rev.1 – Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional

MDCG 2019-5 – Registration of legacy devices in EUDAMED

MDCG 2019-4 – Timelines for registration of device data elements in EUDAMED

MDCG 2021-13 rev.1 – 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

MDCG 2021-1 rev.1 – Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional

MDCG 2022-12 – 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)

MDCG 2020-15 – MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States