According to Article 26 of Regulation 745/2017 on medical devices, a European Medical Device Nomenclature will be available to support the functioning of the future EUDAMED database, as well as to further harmonize the medical devices field in Europe.
The activities to define the European medical device nomenclature started more than a year ago and involved several experts (the MDCG group, experts from EU Commission, experts from each member state). The process has now come to completion and the CND nomenclature, the nomenclature currently used in Italy, has been officially chosen as the new European Medical Device Nomenclature.
The CND nomenclature was initially published in 2007 for the registration of Medical Devices in the Italian national database hosted by the Italian Ministry of Health.
The CND classification categorizes the devices by intended use and/or anatomical-functional location. An alphanumeric code is assigned to each device. The alphanumeric code consists of a letter, identifying the category of the device, a pair of identification numbers of the group to which it belongs, and from a series of other pairs of numbers (stating the level of depth of that part of the classification – max 7), which as a whole identifies the type of homogeneous products.
Further details will be provided by the EU in the next months and manufactures should become familiar with this nomenclature.
Regulatory Pharma Net is at your disposal to offer you support to better manage the transition from the current directive to the new regulation.