According to Article 26 of the new medical device Regulation (MDR) 745/2017 and Article 23 of the new in vitro diagnostic device Regulation (IVDR) 746/2017, the Commission is required to make available a medical device nomenclature in accordance with certain defined requirements, and to support the functioning of the future European Database on Medical Devices, EUDAMED.
In April 2018, the European Medical Devices Coordination Group (MDCG) published a guidance document that provides a detailed description of requirements and criteria that the EU medical device nomenclature is expected to fulfil. The guidance is supposed to serve as a reference basis throughout the decision process and to ensure that all legal and technical issues associated with the future EU medical device nomenclature will be properly traced.
Some of the most important requirements as referred to in both the two regulations and in this guidance document are that access to the EU medical device nomenclature shall be free of charge to manufacturers and other stakeholders and that relevant names and codes in the UDI database of EUDAMED shall also be publically accessible by all relevant operators and to the general public.
With regards to the nomenclature per se, the most important requirements, which are not explicitly mentioned in any of the two regulations, but which are determined by the MDCG, are:
- 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.
Asphalion closely follows news and movements from both the European Commission and the MDCG around the new MDR and IVDR to better assess manufacturers and stakeholders on their implementation.