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.