What is EUDAMED?

What is EUDAMED?

EUDAMED is the abbreviation for European Union Medical Device Database, which is frequently used within the scope of MDR. From the moment the medical device and product is produced, it is open for all parties to follow through EUDAMED. We can define it as a more advanced system than the product tracking system used in our country. In the context of MDR, manufacturers and importers must log into the EUDAMED system and upload the necessary documents.

EUDAMED is a public website consisting of 6 different modules with only three modules active at the moment.

o Registration of Actors
o UDI/Device Registration
o Notified Bodies and Certifications
o Clinical Trials and Performance Studies
o Vigilance and Post-Market Surveillance
o Market Surveillance