European Medical Device Nomenclature required for Medical Device Regulation and In Vitro Diagnostic Regulation submissions
Posted on 05.06.2025
To support consistent and compliant application, MedTech Europe released a practical guide for the use of the European Medical Device Nomenclature (EMDN) to:
- Assist in the identification and assignment of appropriate EMDN codes
- Clarify the structure, categories, and hierarchy of the EMDN
- Explain how how EMDN relates to the Global Medical Device Nomenclature (GMDN) and the Global In Vitro Diagnostic Device Nomenclature (GIVD)
- Guide users in cases where no appropriate code exists, including how to propose new EMDN entries
- Promote alignment in device categorisation across certificates, EUDAMED entries, and notified body documentation
This reference is particularly relevant for regulatory, quality, and technical teams seeking a robust understanding of EMDN requirements and practical implementation strategies.
For more information, please contact Katalin Mate, Senior Expert Regulatory Affairs (IVDR & MDR).