Our Approach to Changes in EU IVDR Regulation
Effective May 26, 2022, the European Union (EU) In Vitro Diagnostics Regulation (IVDR) replaced the In Vitro Diagnostics Directive. This regulation governs how in vitro diagnostics (IVDs) and lab-developed tests (LDTs) are regulated for diagnostic and EU/European Economic Area patient management purposes. In light of how these changes affect relevant assays, Labcorp has produced a comprehensive impact assessment. This assessment informs our strategic approach and recommendations to our sponsors, enabling us to strengthen our support of clinical research and development involving patients from this region.