Theme Assessment of notified bodies 
Target Audience Designating authority, NB 
Products concerned IVD
Documents mentioned IVDR (EU) 2017/746 – article 35 
MDCG 2022-13 

This guidance document is a form template to be used by the designating authority in the context of the evaluation of notified bodies for their initial designation or the extension of their scope of designation under the In Vitro Diagnostic Regulation (IVDR). 

It allows the designating Authorities to document the examination of Notified Body documentation. 

It can be used as a living document during the various steps of the review.