Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced certification for its Guardant360® CDx blood test under the European Union’s In Vitro Diagnostic Regulation (IVDR 2017/746). The certification from TÜV SÜD Product Service is for tumor mutation profiling in patients with any solid cancerous tumor and for companion diagnostic indications to identify patients who may benefit from certain targeted therapies for advanced non-small cell lung cancer and breast cancer.

Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced an updated version of its clinical decision support platform, QIAGEN Clinical Insight Interpret for NGS molecular profiling of hereditary and somatic diseases, has received the European Union (EU) Technical Documentation Assessment and Quality Management System certificate under the European In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR).

The European Parliament has agreed to adopt measures to delay certain deadlines of the In Vitro Diagnostic Medical Devices Regulation (IVDR) and to gradually roll out the European Database on Medical Devices (Eudamed), the European Commission said on Thursday.

Agilent Technologies Inc. (NYSE: A) today announced that its GenetiSure Dx Postnatal Assay has received European IVDR Class C Certification. This certification demonstrates that the assay meets the higher standards established by IVDR. It ensures the continued availability of this trusted qualitative assay to clinical geneticists and other healthcare professionals throughout the EU.

Bio-Techne announced on Friday that its subsidiary Asuragen has received certification under Europe's In Vitro Diagnostic Regulation for its test to monitor chronic myeloid leukemia patients.

The European Commission (EC) has proposed an extension of the transition period for the IVDR, aiming to maintain the availability of essential healthcare products and ensure patient care.

The UK government on Tuesday said it has issued legislation for the implementation of new regulations governing in vitro diagnostics and medical devices.

Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.

CACLP's initiative to launch an English/Chinese webinar for non-EU IVD players in next January is set to provide a crucial platform for understanding EU IVDR registration requirements.