Hartwig Medical Foundation secured CE-IVDR certification for its OncoAct cancer whole-genome sequencing (WGS) analysis software, enabling hospitals to deploy the pipeline for solid tumor patients. Hartwig said the certification reduces hospitals’ need to validate the analysis on their own. The regulatory milestone targets one of the operational bottlenecks for WGS in routine care: standardization and validation effort by clinical laboratories and centers. By formalizing the software as deployable under CE-IVDR, Hartwig’s system moves WGS interpretation closer to scalable clinical workflows. This step reflects continued expansion of clinical WGS utility beyond research-grade setups and into regulated diagnostic decision-making.