What is the European Medical Device Nomenclature?
Recently we updated you on Regulation (EU) 2024/1860 and how this amendment introduces a new approach on mandatory use of certain EUDAMED modules.
Currently, 3 modules are live and those modules are expected to become mandatory in the upcoming year. One of the modules is the UDI/Device module. This module requires manufacturers to register their devices in EUDAMED. Core Data elements that need to be registered in this module is described in Annex VI part B MDR/IVDR. As part of this data, manufacturers are required to enter the “medical device nomenclature code” (EMDN) in EUDAMED. This code can be compared with the Global Medical Device Nomenclature (GMDN) but uses a different structure. Also Notified Bodies will require the manufacturer to provide the EMDN code when applying for certification of their device.
Making the European Medical Device Nomenclature (EMDN) complete | Emergo by UL
Making the European Medical Device Nomenclature (EMDN) complete
Are you a medical device manufacturer doing business in Europe? Learn more about European Medical Device Nomenclature and why is it important for medical device manufacturers.
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