The CND, when Italy is Top of the Class in Europe

From passionate and a bit noisy, Italy, now shy and with thick glasses, was the first to raise its hand.
And the answer caught everyone off guard.

In 2005, the Italian Ministry of Health established that the National Classification of Devices (CND) would be the official classification and nomenclature system for medical devices. About 15,000 manufacturers from around the world have used the CND for registering their medical devices in the Italian database.

As explained in: “The CND Nomenclature – National Classification of Medical Devices” published by the European Union in January 2020, the development of the CND was based on three key principles.

Participatory approach, involving all stakeholders in the development. Qualified validation of proposals and, most importantly, free public availability. Allowing the National Classification of Devices to become a comprehensive and detailed system, capable of managing the heterogeneity of the sector.

The Structure

The CND has a hierarchical structure, on multiple levels: 22 categories, 145 groups and types. This last level expands up to 5 sub-levels to increase the detail of the classification.

The category is identified by a letter, while groups and types are identified by pairs of numbers.

The code thus takes on the following structure: A (category) 02 (group) 01 02 02 01 01 (types) – Disposable infusion and irrigation syringes with three-piece luer lock cone with needle.

On the Ministry of Health’s website, it is possible to consult the latest version of the National Classification of Devices.

CND as Nomenclature in Eudamed

The Medical Device Coordination Group (MDCG) of the European Commission decided, in the meeting of February 14, 2019, to adopt the CND as the official nomenclature for the European database Eudamed. This is thanks to its unique structure, purpose, usability, and updating methodology.

The system, derived from the CND, will constitute a single European system for the classification of medical devices called EMDN.

The European Union, in the document “The European Medical Device Nomenclature (EMDN)” of January 2020, specifies that:

Based on pre-established criteria and requirements and following guidance from the Medical Device Coordination Group (MDCG), the European Commission decided in favor of using the “Classificazione Nazionale Dispositivi medici (CND)” as the foundation for the EMDN.

A success, considering that the (overrated) GMDN (Global Medical Device Nomenclature) was also competing for the title. The paid global nomenclature which, as stated on the Ministry of Health’s website: “Is not a true classification as it does not group medical devices into categories of homogeneous and therefore comparable products”.