In the upcoming EUDAMED database, manufacturers will be using the European Medical Device Nomenclature (EMDN) when registering their medical devices under the MDR.
To serve as a basis for the future EMDN, the Medical Device Coordination Group (MDCG) selected the Italian medical device classification and nomenclature – CND (Classificazione Nazionale Dispositivi Medici).
The CND classifies medical devices in three different levels – Category (first level), Group (second level) and Type (third level) – following an alphanumeric structure.
The alphanumeric code, attributed to every device, will consist in a letter – referring to the Category, followed by two numbers – referring to the Group, and a series of other couples of numbers referring to the Type.
First hierarchical level
Category has 22 different levels, each identified by a letter of the alphabet.
The Categories are divided in:
- Anatomic Categories (8) – defined by anatomical area of use (same specific apparatus, anatomical district or organ or as a replacement of them);
- Functional Categories (9) – defined by intended use or clinical method (devices characterized by similar use, intended use or clinical method);
- Special Categories (5) – by other criteria;
Second hierarchical level
Group has 146 anatomical/functional categories, which represent the various differentiations that distinguish devices contained in the categories.
Inside every Category, Groups are identified by two-digit numbers (01 to 99). The number “90” identifies groups of devices that have several characteristics that are not related to existing groups.
The number “99” – Altri/Others – is reserved to medical devices that are not included in already existing Groups and will be categorized in a later update.
Third hierarchical level
Type may expand into several levels of detail (1°, 2°, 3°, 4° and 5°) and each of them shall be mentioned on the code by two numbers.
Every accessory will have the classification code of the medical device that it is associated with. If an accessory can be used with multiple medical devices belonging to several groups, it must be placed in the prevalent type.
The CND nomenclature is characterized by its hierarchical structure and aims to support the improvement of patient safety and the quality of health systems by enabling information to be communicated in a standardized manner.
Currently, the CDN is being revised to enable the release of the first version of the EMDN. The Commission will map the EMDN to the GMDN, with the aim to facilitate the EMDN code search by operators currently using the GMDN. The correspondence between these two nomenclatures is intended to be visible to operators and incorporated in the future database in the form of searching tool.
A sub-group of the MDCG has been established with the aim to define the rules and processes related to the creation, update, maintenance and use of the European Medical Device Nomenclature. Moreover, the Commission is currently collaborating with the World Health Organization (WHO) in the context of their work and activities on a future international medical device nomenclature.
Alexandra Costa
07.02.2020
Regulatory Affairs Department
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