Introduction
The purpose of this section is to help you navigate through the Notified Bodies and Certificates process of registering certificates module in EUDAMED.
In order to successfully register a certificate in EUDAMED, this section illustrates two scenarios including additional pre-requisite steps when registering a certificate issued for a high-risk class device.
This section assumes the reader is acquainted with the Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices, hence no rules or any other guidance will be provided in relation to certain registration steps.
Warning
EUDAMED does not contain all constraints defined in the MDR/IVDR, guidance and good practices, and therefore, it is not because something is possible in EUDAMED that it is necessarily allowed.