Manufacturers operating under the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) are required to utilise the European Medical Device Nomenclature (EMDN) for regulatory submissions, device registration in EUDAMED, and sampling.
To support consistent and compliant application, MedTech Europe released a practical guide to the use of the European Medical Device Nomenclature which:
- Assists in the identification and assignment of appropriate EMDN codes for devices through relevant examples
- Clarifies the structure, categories, and hierarchy of the EMDN
- Explains how EMDN relates to GMDN and GIVD
- Guides users in cases where no appropriate code exists, including how to propose new EMDN entries
- Promotes alignment in device categorisation across certificates, EUDAMED entries, and notified body documentation
This booklet is particularly relevant for regulatory, quality, and technical teams seeking a robust understanding of EMDN requirements and practical implementation strategies.
