The European Union introduced the IVDR on May 25, 2017, replacing the older IVDD. With a set transition period, IVD manufacturers had until May 26, 2022 to comply with the new regulations.
The IVDR is notable for its comprehensive and complex requirements. Non-compliance can hinder the launch of new products or the reclassification of existing ones.
Ensure you have all the information necessary to conduct a current-state analysis and pinpoint the areas that need to be addressed according to new regulatory requirements in the EU MDR directive.
Download our FREE EU IVDR Guide and other IVDR resources below.
