What is the EU IVDR?

The In Vitro Diagnostic Regulation, Regulation (EU) 2017/746, governs in vitro diagnostic medical devices in the European Union, meaning tests and assays performed on samples such as blood or tissue. It applied from 26 May 2022, replacing the In Vitro Diagnostic Directive. The IVDR introduced a risk-based classification system with four classes, from A for lowest risk to D for highest risk, and dramatically increased the share of devices requiring notified body involvement. It strengthened requirements for performance evaluation, clinical evidence, and post-market performance follow-up, and brought companion diagnostics and certain software clearly into scope. Because notified body capacity was limited when the regulation applied, the EU adopted extended transitional timelines that phase in the requirements for existing devices by risk class over several years.