The European Medical Device Nomenclature is an essential document for all MD manufacturers who wish to place their products on the market. The first, essential step is to define the class assigned to the product. This is indeed of great importance. This step will define the regulatory requirements which will need to be met to ensure the device’s compliance. There are four classification levels (I, IIa, IIb and III) ranging from the lowest to the highest risks.
The Medical Device Nomenclature (EMDN), used by manufacturers during the EUDAMED registration process for medical devices, has an alphanumeric structure. It has a seven-level hierarchical tree. It clusters medical devices into three main levels: categories, groups and, the last level, types. These types are available on several levels. The alphanumeric code generated starts with a letter that refers to the category of the device. The next two numbers refer to the group, and the last series of numbers to the type of MD. However, a maximum limit has been set аt 13 characters.
Therefore, manufacturers must thoroughly assess the impact of extended definitions and classification changes in relation to their current and future product portfolios. Requirements differ based on the product classification.
To learn more about the European Medical Device Nomenclature, please view our FAQ below. Do not hesitate to contact us for more information.
