Natera’s Signatera MRD test received certification under the EU’s IVDR framework for multiple cancers. The certification covered the assay platform components, including specimen collection kit and associated software, after review of analytical and clinical validity evidence. The IVDR clearance extends the availability of MRD-directed monitoring into more regulated European settings, supporting trial and potentially clinical use cases where minimal residual disease status is used to guide treatment decisions. For MRD testing suppliers, the certification also functions as a quality and evidence threshold that can affect payer adoption and partner trial protocols.