QIAGEN Clinical Insight Interpret is the first NGS interpretation platform to be certified under IVDR for both oncology and hereditary applications
QIAGEN is pleased to announce 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).
QIAGEN Clinical Insight Interpret is the first NGS interpretation platform to be certified under IVDR for both oncology and hereditary applications. As a medical device software for clinical decision support (Class C IVD Medical Device), QIAGEN Clinical Insight Interpret conforms with regulatory policy, ensuring greater patient protection, information transparency, and data traceability. The updated certified version will be available for customers in Europe later in 2024, depending on requirements for sale in respective countries.
“Receiving IVDR certification for QIAGEN Clinical Insight Interpret is further confirmation that our clinical customers benefit from a high-quality and regulatory compliant software that allows scaling and acceleration of critical turn-around times and workflow efficiencies. Our Augmented Molecular Intelligence approach to content curation and analysis that has been leveraging humans as well as Artificial Intelligence (AI) and Machine Learning for over 20 years delivers highly accurate and repeatable interpretation essential for clinical decision support.”
Jonathan Sheldon, PhD
Senior Vice President of QIAGEN Digital Insights
European labs and clinicians are facing significant changes to diagnostic testing. Announced in May of 2017, IVDR is the new regulation for in vitro diagnostic medical devices in Europe. It replaces IVDD (in vitro diagnostic directive). In essence, the European Union is moving from a directive-based system to an approach that now is European regulation. Advances in testing, technology and international standards were considered in the development of the IVDR regulation, resulting in changes to provide higher quality, safety and reliability of IVD tests and devices.
MedTech Europe welcomed the adaption of the European Commission’s amendment to the In Vitro Diagnostic medical devices Regulation (IVDR) by the European Parliament and the EU Council, that has been published in the Official Journal of the EU. Since this publication date, the amendment is fully applied in all Member States and has the effect of:
QIAGEN welcomes the progressive roll-out of the regulation based on the IVDR risk class. This phased approach ensures the supply of key diagnostic tests while the healthcare community continues to deal with the COVID-19 pandemic.
→ Read more about the amended provision here: MedTech Europe.
→ Read the Official Journal of the European Union amending Regulation (EU) 2022/112.
While IVDR changes will provide increased assurance throughout diagnostic testing across European healthcare systems, there are certain to be questions along the way. Successful transition to new IVDR standards requires preparation.
At QIAGEN, we are deeply invested and committed to the transition. Since the inception of the IVDR, QIAGEN has been at the forefront of the evolution and implementation of the regulations. QIAGEN proudly serves on multiple committees and works closely with MedTech Europe in the discussions with the European Commission.
IVDR certification ensures that medical device software used in laboratories complies with stringent regulatory standards, guaranteeing its safety, reliability, and effectiveness. Having IVDR-certified medical device software is crucial for labs to maintain quality control, ensure accurate diagnostic results, and adhere to regulatory requirements, thereby safeguarding patient well-being, enhancing the lab’s credibility, and enabling international collaborations.
Contact us
For questions and more information regarding QIAGEN IVDR support and the European IVDR certification of QIAGEN Clinical Insight Interpret, please send an email to our customer support team at ts-bioinformatics@qiagen.com.
