Guide to IVDR conformity assessment procedures
Manufacturers looking to launch their in vitro diagnostic device (IVD) within the European Union need to comply with the relevant EU in vitro diagnostic device regulations.
In Vitro Diagnostic Device Regulation (IVDR) guide
This In Vitro Diagnostic Device Regulation (IVDR) guide will give you an overview of the key areas of focus and changes within the regulation.
How to classify your IVD
This guide will help you classify your in vitro diagnostic device - an important first step for manufacturers who are getting their devices into the European market.