According to recent reports, Italian medical device CND nomenclature (Classificazione Nazionale dei dispositivi medici) will be utilized as basis for the Eudamed database, the information system for exchanging legal information related to the application of European Union Directives on medical devices.
This important decision is indeed fundamental for Eudamed developing, because each device must be connected to the nomenclature terms as part of the unique identification data (UDI).
Main objective for Eudamed action is to help European authorities conduct market surveillance on medical devices through information exchange.
EUDAMED will also develop a vigilance module, to inform Member States on incidents or near-incidents in relation to certain devices on the market.
Eudamed provides numerous and different data, inter alia:
- Data related to registry of manufacturers, authorized representatives and devices;
- Data related to certificates issued, modified, supplemented, suspended, withdrawn or refused according to established procedures;
- Data obtained in accordance with the vigilance procedure on incidents or near-incidents which occur during the use of the medical device.
CND codes from the Italian Ministry of Health will be mapped to Global Medical Device Nomenclature (GMDN) for ease of use by manufacturers and other entities utilizing Eudamed.
The Italian coding system has been in use since 2007 to support state device database, and it’s continually updated and used on a daily basis.
Milan, March 2019.