IVDR readiness for oncology

QIAGEN is committed to easing the transition from the In Vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Medical Devices Regulation (IVDR).

We are working to meet the latest standards that hold more stringent regulatory requirements and will continue to provide labs and healthcare professionals with the oncology products necessary to give patients the answers they need.

The In Vitro Diagnostics Medical Devices Regulation (IVDR) is the new, harmonized regulatory framework created to assure the highest standards of quality, safety and performance of in-vitro diagnostic devices on the market in EU member states. The IVDR has gone into effect on May 26, 2022 and replaces the existing IVDD.

We are committed to the highest standards of quality and have pledged full compliance with the new rules. In 2021, we completed the required audit of our quality management system (QMS) through a notified body without major observation. This marked our first key milestone towards IVDR compliance.

The EU Quality Management System certificate, delivered by an independent notified body, reinforces our dedication to offering CE-IVD products with the highest analytical & clinical quality and performance standards.

Following this significant step, we will continue working towards receiving the required certifications for our entire oncology IVD portfolio.