Nordic Biomarker proudly announces IVDR certification for D-Dimer!
We are excited to share that our D-dimer reagents and their associated calibrators are now officially CE-marked according to IVDR! This is a big milestone for us, as these are our first products to achieve certification under the In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746). As a result, our related documentation has been updated to align with these standards, which may assist you in your certification process.
This certification guarantees the continued availability of our D-Dimer reagent under the new EU regulations, ensuring reliable, high-quality diagnostic solutions. And this is just the beginning! Our entire product portfolio is transitioning to IVDR compliance, with several more certifications already underway. Stay tuned for further updates as we continue this journey!
If you have any questions or need further assistance, please do not hesitate to reach out to your sales contact or contact us at sales@nordicbiomarker.com. We are happy to help!
Warm regards,
The Nordic Biomarker Team