European Medical Device Nomenclature (EMDN)

EUROPEAN MEDICAL DEVICE NOMENCLATURE (EMDN)

European Medical Device Nomenclature (EMDN) is the nomenclature that will be of use to the manufacturers when registering their Medical Devices in the EUDAMED database. It has risen from the requirement in Article 26 of EU MDR 2017/745 and Article 23 of IVDR 2017/746.

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

The manufacturers should register their medical devices with this nomenclature code in the UDI Database which is part of the EUDAMED.

Classificazione Nazionale Dispositivi Medici (CND) is the Italian medical device classification and nomenclature set out by the Italian Ministry of Health in 2005. The CND is the basis for the EMDN which in turn will support the functioning as stated by the MDCG.

As per the latest knowledge, an extraordinary revision of the CND is continuing so that to release the first version of the EMDN, it will have to be integrated into EUDAMED for use by operators such as manufacturers or economic operators. The EMDN is going to be fully available and accessible to any operators and will be copyright free.

What is the relevance of EMDN in the MDR technical documentation?
Who is issuing the EMDN for the medical devices? Is this EMDN required to use on the medical device labeling?