Conformity Assessment Procedures
This guide will help manufacturers looking to launch their in vitro diagnostic device (IVD) within the European Union (EU) comply with the relevant EU in vitro diagnostic device regulations.
The first step in the process is for manufacturers to classify their in vitro diagnostic device based on the requirements in the new In Vitro Diagnostic Device Regulation (IVDR).
Then, based on the classification of the IVD, manufacturers can identify the appropriate conformity assessment route for their product. This route will determine the required activities manufacturers will need to comply with in order to receive a CE marking.