New EUDAMED FAQ: Comprehensive Answers to Your Questions About the EU Medical Device Database
We are pleased to announce that we have expanded our website with a new, comprehensive FAQ section on the European Database for Medical Devices (EUDAMED). This resource provides you with practical answers to the most common questions regarding the use of and requirements for EUDAMED.
What you’ll find in our FAQ:
- Actors & Roles: Clarification of the various actor roles, links between importers and manufacturers, and registration requirements
- Product Registration: Detailed information on deadlines, requirements for different product classes, and step-by-step guides to implementation
- Data Structure & Mandatory Information: Explanations of required entries, correct form completion, and the meaning of specific fields
- Grouping & Coding: Assistance with sensible product grouping and handling of UDI codes
- System Functions: Tips for efficient use of the EUDAMED user interface and avoiding duplicate work
- Relationship to National Systems: Clarification of the interplay between EUDAMED and national databases
Continuous Updates
Our EUDAMED FAQ will be regularly updated and expanded to provide you with the most current information and answers to emerging questions. We will keep you informed about important changes and additions in this area.
Do you have a specific question about EUDAMED that is not yet answered in our FAQ? Don’t hesitate to contact us – your feedback helps us to further improve and adapt our information.
Related Posts