Oct 11, 2021

European Commissioners have launched additional modules for the Eudamed medical device and in vitro diagnostic (IVD) product database developed to improve European market transparency.

According to a European Commission update to the Eudamed overview page, two additional modules out of a planned six have gone live in early October: UDI/Devices Registration as well as Notified Bodies and Certificates. The launch of these modules follows the rollout of the Actor Registration module in December 2020.

This means that Economic Operators—manufacturers, EU Authorized Representatives, importers and distributors—as well as Notified Bodies may begin entering data on a voluntary basis pertaining to these modules:

  • UDI/Devices Registration: Economic operators will enter UDI and registration information for devices into this module
  • Notified Bodies and Certificates: CE Mark certificates as well as quality management system certifications issued by EU Notified Bodies will be entered into this module

Three additional modules—Clinical Investigations and Performance Studies; Vigilance and Post-market Surveillance; and Market Surveillance—will launch when the Eudamed database becomes fully operational in May 2022.

Additional Eudamed and EU medical device regulatory resources from Emergo by UL:

Author

  • Stewart Eisenhart

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