• Feature ArticlesFeature Articles

    Complying With the new EU IVDR

    This article discusses processes and plans that need to be developed by In Vitro Diagnostic (IVD) companies to address the new EU In Vitro Diagnostic Regulations (IVDRs) in advance of their coming into full force in 2022. Issues discussed include the differences between IVD and IVDR, new IVD classifications, notified bodies, new clinical evidence requirements and when to begin transitioning to the new requirements. Introduction On 5 May 2017, the In Vitro Diagnostic Re...