The European Commission (EC) has released documents outlining the principles behind EUDAMED’s nomenclature.
The European Medical Device Nomenclature (EMDN) will be the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database, as per the incoming Medical Device Regulation (MDR).
Being characterised by its refined and hierarchical structure, the Italian “Classificazione Nazionale Dispositivi medici” (CND) was selected as the foundation of the EMDN. Over 15,000 manufacturers from various countries such as Italy, Greece and Portugal have used the CND for registration of their devices in the Italian database. The CND aims to “support the improvement of patient safety and the quality of health systems by enabling information to be communicated in a standardised manner”.
The CND system works by classifying medical devices with a corresponding alphanumeric code. The code comprises a letter referring to the device category, such as cardio-circulatory or dialysis, then a series of number referring to the device type and group.
The first version of EMDN will be integrated in EUDAMED, copyright free and fully accessible to any operators. The Medical Device Coordination Group (MDCG) have formed a subgroup to supervise regulatory activities related to nomenclature, such as creation, update and maintenance of the EMDN. Furthermore, the EC is collaborating with the World Health Organisation (WHO) on plans for future international medical device nomenclature.
More information on the CND structure for use with EUDAMED can be found in this guidance.