EU: the criteria for the future EMDN for the EUDAMED nomenclature have been established

The new nomenclature to use during the medical devices registration in EUDAMED database will be called European Medical Device Nomenclature” (EMDN).

person makes medical devices registration in EUDAMED database
The criteria for the future EMDN for the EUDAMED nomenclature have been established.

The European Commission, indeed, has drawn up recently the guide line: “The European Medical Device Nomenclature (EMDN) – the nomenclature of use in EUDAMED”, establishing the criteria to be followed for EMDN drawing up.

Specifically, the European Commission detected the “Medical Devices National Classification” (MDNC) – currently used in Italy, Portugal and Greece – as starting point for the future EMDN. A MDNC review is now under way followed by EMDN first version publication to be incorporated in EUDAMED for the operators use.

EMDN will be completely available to each operator and it will be copyright free.

Medical devices will have to be identified with an alphanumeric code (including a letter) and corresponding to the device category (i.e cardio-vascular, dialysis), as well as a series of numbers referred to the device type and group.

The objective of this operation is to ease the EMDN codes research also to the operators that currently use Global Medical Device Nomenclature (GMDN).

The connection between the two nomenclatures will be incorporated in the EUDAMED database as a “searching tool” to ease the research to the operators.

Database mapping and creation is ongoing but medical devices manufacturers will be required to adapt to the new nomenclature criteria only when EMDN will be defined and integrated in EUDAMED database.  

Source: https://ec.europa.eu/docsroom/