Natera said its Signatera minimal residual disease (MRD) platform has received IVDR certification for multiple cancers. The certification review covered the assay, specimen collection kit, and supporting software, including evidence for analytical and clinical validity. For oncology diagnostics developers, IVDR marks a key European regulatory milestone that can unlock broader commercial distribution and hospital adoption once local procurement and reimbursement align. Natera’s announcement also strengthens its position in ultrasensitive ctDNA monitoring as more clinical workflows move toward molecular response assessment. The company did not provide segment-level performance in the summary materials, but the certification itself is a meaningful gating item for European rollouts.