MDCG 2021-12 Rev.1 FAQ on the European Medical Device Nomenclature (EMDN)

MDCG 2021-12 Rev.1 FAQ provides a detailed explanation of the European Medical Device Nomenclature (EMDN), which is an essential resource for ensuring the compliance of medical devices and IVDs in the context of the European Union's MDR and IVDR regulations. With the January 2025 revision, this document guides manufacturers on how to correctly assign EMDN codes to their devices in EUDAMED. In addition, it clarifies aspects of the hierarchical structure of the nomenclature, the use of alphanumeric codes, and the annual nomenclature update process.