Qiagen gets European IVDR certification

The company states: “QIAGEN announced that its QIAstat-Dx syndromic testing systems and associated assays have received CE-marking under the European Union’s new In-Vitro Diagnostic Medical Devices Regulation, or IVDR. This certification includes the widely-used QIAstat-Dx Analyzer, QIAstat-Dx Rise, and panels for detecting gastrointestinal and respiratory illnesses. The achievement underscores QIAGEN’s commitment to meeting the highest standards of safety, quality, and performance, as it has already transitioned 80 percent of over 180 products to the new regulatory framework. The new IVD regulation aims to ensure the safety, quality and effectiveness of in-vitro diagnostic devices, overseen by independent organizations in the EU known as Notified Bodies. Devices are now classified by risk level, from Ato D. The QIAstat-Dx instruments, QIAstat-Dx Analyzer 2.0 and QIAstat-Dx Rise, are classified as Class A devices, while the QIAstat-Dx Gastrointestinal Panel 2 is classified as a Class C device. The QIAstat-Dx Respiratory Panel Plus is classified as a Class D device – the highest risk category – highlighting QIAGEN’s capabilities to meet highest regulatory thresholds in Europe. The submission for IVDR certification of the QIAstat-Dx Meningitis/Encephalitis Panel is expected in the coming months.”