Guidance published by EU-commission on obligations and related rules for the registration in EUDAMED

News • 29.06.2021

EUDAMED is the medical device database developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis (IVD) medical devices. Main purpose of the database is to improve transparency and coordination of information regarding medical devices available on the EU market.

EUDAMED contains following 6 interconnected modules: 1) Actors registration, 2) UDI/Devices registration, 3) Notified Bodies and Certificates, 4) Clinical Investigations and performance studies, 5) Vigilance and post-market surveillance, 6) Market Surveillance. Currently only one of the modules is open: the module on Actor registration has been available since December 2020. The 2nd and 3rd modules (UDI/device registration, Certificates and Notified Bodies) will become available in September 2021.

Actor registration module combines information from different Economical Operators (Legal manufacturers, importers, authorized representatives, system and procedure pack assemblers). The Commission has stated that they are not in a position to require the use of the module until EUDAMED is fully functional according to the Medical Device Regulation (MDR) and therefore additional national requirements on registrations can exist. For example, in Finland, National Competent Authority Fimea requires that legal manufacturers, authorized representatives, system and procedure pack assemblers and importers that place medical devices on the market under Regulations (2017/745) and/or (2017/746) are required to register with EUDAMED.

To guide registration activities, EU-Commission has released a Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorized representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR in June.

Find out more from EU-commission webpage:

https://ec.europa.eu/health/md_eudamed/overview_en

and https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2021-13_q-a-actor_registr_eudamed_en.pdf

For actor module please visit:

https://ec.europa.eu/health/md_eudamed/actors_registration_en