Eudamed requirements ahead of Eudamed
Eudamed is one of the key drivers of the European Medical Devices Regulation (EU) 2017/745 (MDR) and the In-Vitro Diagnostic Medical Devices Regulations (EU) 2017/746 (IVDR). The European Database for Medical Devices, Eudamed, is intended to store and provide information on the manufacture, distribution, certification and post-market surveillance of devices. Both MDR and IVDR contain several articles that refer to Eudamed. The application of the MDR has been delayed by one year, until May 26, 2021.

