Understanding the EU Conformity Assessment Process for in vitro diagnostic devices

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.

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 European Union.

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.

As a leading Notified Body with more than 20 years’ experience in the medical arena, LRQA can help you verify the requirements relating to your products, and work with you to determine the best options for conformity assessment, including any other services we can help you with. 

Click on the image below to download

Image - IVDR Conformity asessment