Nomenclatures for Medical Devices
To support the legal tasks, it is essential to use a standard nomenclature for medical devices. BfArM publishes a German-language version of the Universal Medical Device Nomenclature System (UMDNS) on behalf of the Ministry of Health (BMG). The English-language classification of the European Diagnostic Manufacturers Association (EDMA) is used to code in vitro diagnostics.
UMDNS and EDMS are integrated into the registration systems with search functions and can be downloaded free of charge.
UMDNS and EDMS are to be replaced in future by the European Medical Device Nomenclature (EMDN). The EMDN is based on the Italian Classificazione Nazionale Dispositivi medici (CND) and is provided free of charge. The EU Commission is striving to publish the EMDN in all national languages in time for the MDR to become valid on 26 May 2020. We will provide information about a concrete introduction date and the functioning of the EMDN on this website at the appropriate time.
ECRI Institute, USA developed Universal Medical Device Nomenclature System (UMDNS) with the object of coding medical devices.
The product classification of the European Diagnostic Manufacturers Association (EDMA) is used to code in vitro diagnostic medical devices.