January 10th, 2020, the European Commission released new documents on the European Medical Device Nomenclature (EMDN) basic principles and the structure of the Italian “Classificazione Nazionale Dispositivi medici” (CND), which was selected in March 2019 as the basis for the future European Medical Device Nomenclature.
The first document, titled “The European Medical Device Nomenclature (EMDN) – the nomenclature of use in EUDAMED”, explains in short how at this point in time a revision of the CND is ongoing to convert to EMDN which will be integrated in EUDAMED.
The second document, titled “The CND Nomenclature – background and general principles” provides information regarding the basic principles and the structure of the Italian CND.
The system works by classifying each medical device with an alphanumeric code consisting of a letter referring to the “Category,” such as W for in vitro diagnostic devices. This is the 1st level of the nomenclature. The second level of the nomenclature consists of two digits referring to the device “Group”. The third to, maximum seventh level of the nomenclature consists of a series of additional pairs of digits specific to the “Type” of device. More details on the CND structure are included in the guidance.
Please note that the term “category” and “group” in the CND nomenclature should not be confused with the term “category of devices” or “generic device groups” used in Article 52(4) and (6) of the MDR and Article 48 (7) and (9) of the IVDR establishing the need to assess the technical documentation of at least one representative device per generic device group (for Class IIb and Class C) or per category of devices (for Class IIa and Class B) prior to issuing the certificate. The correct definition of a “generic device group” and of a “category of devices” was stipulated in MDCG 2019-13.
The CND nomenclature is important in the definition of “generic device group” used in Article 52(4) of the MDR and Article 48(7) of the IVDR. According to the MDCG 2019-3, a generic device group has been defined as:
- For Medical Device (MDR): the 4th level of the EMDN (i.e. combination of one letter plus 6 digits);
- For in vitro diagnostics (IVDR): the 3rd level of the EMDN (i.e. combination of one letter plus 4 digits respectively) in combination with the most appropriate IVP code.
What does this mean to you?
These documents provide you with useful insights as to how the “Classificazione Nazionale Dispositivi medici” (CND) is currently organised and can be of value in determining the generic device groups you will have within your portfolio. This will allow you to estimate the amount of generic device groups you must discuss with your notified body.
The EMDN itself is a core data element to input into EUDAMED as per IVDR Annex VI Part B (8).
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.