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The purpose of this user guide is to help you navigate through the Notified Bodies and Certificates process of registering certificates module in into EUDAMED.1

In order to successfully register a certificate in EUDAMED, this guide illustrates two scenarios including additional pre-requisite steps when registering a certificate issued for a high-risk class device.

This guide 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.