Making the European Medical Device Nomenclature (EMDN) complete

By Annette van Raamsdonk

What is the European Medical Device Nomenclature?

Recently we updated you on Regulation (EU) 2024/1860 and how this amendment introduces a new approach on mandatory use of certain EUDAMED modules.

Currently, 3 modules are live and those modules are expected to become mandatory in the upcoming year. One of the modules is the UDI/Device module. This module requires manufacturers to register their devices in EUDAMED. Core Data elements that need to be registered in this module is described in Annex VI part B MDR/IVDR. As part of this data, manufacturers are required to enter the “medical device nomenclature code” (EMDN) in EUDAMED. This code can be compared with the Global Medical Device Nomenclature (GMDN) but uses a different structure. Also Notified Bodies will require the manufacturer to provide the EMDN code when applying for certification of their device.   

Where can I find the EMDN codes?

The EMDN codes are free of charge and can be found on the European Commission’s (EC) dedicated website here. The EMDN has an alphanumeric structure and has seven levels and 3 layers (categories, groups, type(s)). Each level covers a certain category of devices and is further specified in groups and types of devices. Manufacturers will choose the lowest available level of the EMDN code that bests fits the intended use and characteristics of their device. Additionally, MDCG 2021-12 rev.1 FAQ on the European Medical Device Nomenclature (EMDN) gives an exemption specifies that “as a general rule, manufacturers must always identify the singular most appropriate code to associate with the UDI-DI of the device in question.”. Exemptions from this rule are according to this FAQ only foreseen for devices with multiple-intended purposes, such as complex systems. In those cases, more than one code may be used.

The GMDN code and term that you have assigned to your device, will be different from the EMDN code and term, therefore it is important to check what code applies for the EU.

What if my device isn’t covered by any of the codes?

The EMDN is reviewed and updated annually. For this input is needed and collected. Requests for new codes can be submitted by all Economic Operators, as well as CAs, NBs, the World Health Organization (WHO), trade associations, and so on.

Changes and revision

The procedure for updating the EMDN codes is described in MDCG 2024-2 rev.1, which was recently changed, to insert an Ad Hoc procedure. The Ad Hoc procedure is described in a separate document, allowing NBs and CAs to submit a request to add a new code to the existing EMDN codes. A dedicated form is created, MDCG 2025-1 EMDN Ad hoc procedure. Additionally, the EC has published the version history of the EMDN codes (MDCG 2025-3) as well as the summary of EMDN 2024 submissions and whether these have been accepted or not (MDCG 2025-2).

Struggling with what EMDN code fits your device best? Reach out to us!