Manufacturers operating under the (EU) 2017/745 Medical Device Regulation (MDR) and (EU) 2017/746 In Vitro Diagnostic 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 for the use of the EMDN to:
- Assist in the identification and assignment of appropriate EMDN codes
- Clarify the structure, categories, and hierarchy of the EMDN
- Explain how EMDN relates to GMDN and GIVD
- Guide users in cases where no appropriate code exists, including how to propose new EMDN entries
- Promote alignment in device categorization across certificates, EUDAMED entries, and notified body documentation
