What is EUDAMED?
EUDAMED is a database used for registering medical device information across Europe. The database serves for transparency and coordination of information.
MDCG has published the following guidance for EUDAMED
- 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
- 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 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
In order to reach EUDAMED documents, please visit the EU Commission Official Webpage
/health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en#current-guidance
Szutest GmbH is a Notified Body designated under MDR regulation. To learn more about our services, please visit https://www.szutest-germany.de/en/medical-devices/
To reach out to Szutest GmbH, please visit https://www.szutest-germany.de/en/contact/