The purpose of this document is to help Competent Authorities, Notified Bodies, as well as all Economical Operators (Manufacturers, Authorised Representatives, Importers, and System/Procedure Pack Producers) in assessing the most cost-efficient solution for their needs to comply with the Medical Devices Regulation.
Although EUDAMED offers multiple ways of inputting/downloading data, there are several
parameters to take into consideration before making a decision.