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IVDR CONFORMITY ASSESSMENT Guide

Understanding the conformity assessment process for IVDs.

Manufacturers looking to launch their in vitro diagnostic device (IVD) within the European Union (EU) need to comply with the relevant EU in vitro diagnostic device regulations.

The CE marking is a legal demonstration that the manufacturer’s product has met the relevant regulatory requirements of the EU.

The CE marking process can, at first, seem a daunting process even for the most seasoned regulatory affairs professionals, so we have simplified it into two compact guides which you can download for free.

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.

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