European Medical Device Nomenclature

Manufacturers will use the European Medical Device Nomenclature (EMDN Code) when registering their medical devices in the EUDAMED database.

Article 26 of EU 2017/745 Regulation on Medical Devices (MDR) and Article 23 of EU 2017/746 Regulation on In-vitro Diagnostic Devices (IVDR), the European Medical Device Nomenclature (EMDN) aims to support the functioning of the European database (EUDAMED). Among its various uses, it will be utilised by manufacturers for the registration of medical devices in EUDAMED, where it will be associated with each Unique Device Identifier – Device Identifier (UDI-DI).


It would facilitate effective market surveillance operations and facilitate device traceability throughout the supply chain. The European medical device nomenclature will be free of cost to the manufacturers and other natural/legal persons required by the regulations to use this nomenclature.

How is the EMDN structured?

The EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree. It clusters medical devices into three main levels:

  • Categories: the first hierarchical level,
  • Groups: the second hierarchical level,
  • Types: the third hierarchical level (which expands into several levels of detail (1°, 2°, 3°, 4° and 5°), where necessary.

Each alphanumeric code begins with a letter referring to the ‘CATEGORY’ for which the device falls, followed by two numbers indicating the ‘GROUP’ and a series of numbers which refer to the ‘TYPE’. The maximum number of digits is set at 13.


During EUDAMED registration or technical documentation, manufacturers always assign the most granular and terminal term available (lowest level in the tree) to their device.

EMDN codes are now mandatory for every medical device within the EU, to be included either during the preparation of technical documentation, the NB application process, or the registration on EUDAMED

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