EU IVDR and Its Impact on Diagnostics Trials
EU IVDR and Its Impact on Diagnostics Trials How EU IVDR Transforms the Landscape for Diagnostic Trials Introduction to IVDR and Its Relevance to Clinical Diagnostics The European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR, Regulation (EU) 2017/746) replaced the previous IVDD (Directive 98/79/EC) and entered into force on May 26, 2022. The IVDR…