The European Commission Unit dealing with medical devices – newly under the Directorate for Health and Food Safety (move from DG GROW to DG SANTE) – published two new documents related to the future European Medical Device Nomenclature (EMDN).
As announced in 2018, the Italian medical device classification nomenclature (CND) will be used as the basis for the future EMDN that will be integrated in EUDAMED. For this purpose, the CND is currently under revision and its structure, updates and revisions are presented in the newly published document.
The European Commission also stated that:
“The EMDN will be fully available and accessible to any operators and will be copyright free.”– as envisaged in Article 26 of the MDR and Article 23 of the IVDR.
In addition to the revision of the Italian nomenclature, there is an ongoing work of mapping the EMDN to the Global Medical Device Nomenclature (GMDN) with “the hopes of possibly facilitating EMDN code search by operators currently using GMDN”. This is in view of the intention to incorporate a searching tool in the future database.
Finally, the European Commission mentions ongoing collaboration with the WHO (World Health Organization) on a future international medical device nomenclature.
We will keep you informed on the state-of-play of the future EMDN our News section!