Questions & Answers from the European Commission on the European Medical Device Nomenclature (EMDN)

The European Commission has just published a document gathering questions and answers on the EMDN.

In accordance with Article 26 of Regulation (EU) 2017/745 on medical devices and Article 23 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices, the EMDN aims to support the functioning of the EUDAMED database. Among its various uses, the EMDN will be used by manufacturers for the registration of their MD and IVD MD in EUDAMED where it will be associated with the UDI-DI.

This document specifies the definition of EMDN, its objective, its key principles, its access, its structure and the level of the EMDN to be used to assign a code to a medical device.

DOWNLOAD Q&A ON EMDN