European Medical Device Nomenclature 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 EMDN 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 European medical device nomenclature, 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.
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Currently we are using GMDN code in Technical file, as said in above content that The European Medical Device Nomenclature (EMDN) will be the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database, so once EMDN is established manufacturer would have to include EMDN along with Unique Identification Number in Technical File
The medical devices nomenclature is a coding system and used for classification and identification of all medical devices generically. There are several nomenclature systems presently existing and they are used by different groups of professionals, based on their specific needs. As the European Commission wants to maintain EUDAMED, as per the new regulations, it requires a unique nomenclature system, that can be freely available to all the groups.
For the same, they want to develop European Medical Device Nomenclature system, by referring the CND and GMDN. At present the process is going on.
Mentioning the EMDN in technical documentation and labels, will be beneficial for the better communication between individuals and organizations.
For registering medical devices under MDR, the manufacturer shall use European Medical Device Nomenclature (EMDN) with the help of the upcoming EUDAMED database.
Currently, the CND is being revised to enable the release of the first version of the EMDN. The commission will map the connection between the two nomenclatures GMDN and EMDN will be incorporated in the EUDAMED database as a “searching tool” to ease the research to the operators.
I don’t know what to comment on because I don’t understand what that means yet