- That the nomenclature is internationally recognized. For this purpose, global harmonization principles and orientations followed and adopted by the International Medical Device Regulators Forum (IMDRF) and the World Health Organization (WHO), shall be especially taken into account;
- That ,the system is multilanguage, whereby a recognition of names and a description is provided in all official EU languages, which is considered highly important;.
- That the structure and design of the nomenclature facilitates the establishment of links with codes defining notified bodies competence (designation scope) and defining quality management system (QMS) certificates and product portfolios.
- That the nomenclature has a hierarchy by which terms and codes are meaningfully grouped in categories and subcategories;
- That the nomenclature system adequately supports the functioning of the EUDAMED database
- That the nomenclature system is kept up-to-date at any time, with regards to terms and descriptions, and which shall be regulatory updated by a nomenclature provided with new information from ongoing experience as well as from technological innovation, by following defined procedures.
As Brexit is quickly coming closer, the CMDh has published an updated version of the Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP in December 2020.