Juni 11, 2025
Regulatory

European Medical Device Nomenclature Required for MDR and IVDR Submissions

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.

Download Practical guide for the use of European Medical Device Nomenclature (external link)

Source: MedTech Europe Aisbl