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Medical Devices

Pre-Conference Workshop: EUDAMED

Monday, May 6, 2024
08:30 – 16:00 CEST
Location: B 07 + B 08
Ticketed Event Learning Level: Advanced
Description: EUDAMED comprises of 6 different inter-connected modules and is expected to play a critical role in the functioning of MDR and IVDR. Three of the six modules - Actor registration, UDI/Device registration and NB certificates modules are now available for voluntary use. The new EC proposal to amend MDR/IVDR includes provisions to make the available EUDAMED modules mandatory individually and independent from the other modules yet to go live. The workshop will provide an overview of the requirements, proposed timelines, practical demonstration of the available EUDAMED modules and discuss experience so far including possible problems, pitfalls and potential recommendations for working and interacting with the EUDAMED database.

The Preconference workshops are not included in the Main Conference registration. You can register for the workshop via the website: Visit the website!

Learning Objectives:

  • Understand the basics of EUDAMED and projected timelines for the EUDAMED modules to go functional and mandatory.
  • Learn and understand how to use the available EUDAMED modules with practical examples.
  • Learn and understand how information is shared between various modules and what information will EUDAMED make publicly accessible.