EU IVDR Milestone: Cancer Biomarker Test First To Get A Companion Diagnostic CE Marking
A major milestone has been reached in the EU after a cancer biomarker assay became the first product to receive a companion diagnostic certificate in the context of the EU In Vitro Diagnostic Regulation.
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EU MDR Notified Bodies Reach 38 After Another Designation
Germany’s SZUTEST is the latest notified body to be designated under the EU Medical Device Regulation, bringing the total number to 38.