Agendia, Inc. today announced that it has obtained certification from the European Union (EU) In Vitro Diagnostic Medical Device Regulation (IVDR) for three products, including its MammaPrint® FFPE Microarray, BluePrint® FFPE Microarray, and MammaPrint and BluePrint NGS Kit. These products are classified as Class C under this regulation. This certification recognizes Agendia’s strict adherence to rigorous quality and safety standards and ensures the tests’ reliability and effectiveness in clinical settings across the EU.

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

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.

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

Illumina said on Tuesday that it has received a decision from the European Commission that will prohibit the firm from keeping liquid biopsy maker Grail.

The world is in a "race against time" with the Omicron coronavirus variant, said European Commission President Ursula von der Leyen on Sunday, warning during a visit to Latvia that scientists and manufacturers will need weeks to fully understand the new variant.