Institut Virion\Serion GmbH is proud to announce a significant milestone: the company received the IVDR (In Vitro Diagnostic Regulation) certification for its Class B products. The certificate, issued on February 12, 2025 (Certificate Number: HX 1098896-1), confirms the company’s commitment to meeting the rigorous standards set by REGULATION (EU) 2017/746 on In Vitro Diagnostic Medical Devices.
This certification, which includes both Class B and Class C products, confirms that Institut Virion\Serion’s products are in full compliance with Annex IX Chapter I, Section 2 and 3, and Chapter III of the IVDR.
IVDR-Certified Product Groups
All products of the following product groups are now officially certified under the IVDR:
- SERION ELISA classic (ESRxxx)
- SERION ELISA antigen (ESR200)
- SERION ELISA control (BCxxx)
- SERION immunoCONTROL (ICxxx)
- SERION ELISA AI control (CLSxxx)
- SERION ELISA Avidity Control (BRxxxAVID)
- SERION ELISA Avidity Reagent (BxxxAVID)
- SERION RF Absorbent (Z200)
With the completing of IVDR certification for all class B and C SERION ELISA products, we are one of the few companies to have completed IVDR certification for their product portfolio.
This achievement solidifies the company’s leadership in ensuring highest standards of quality and compliance in the diagnostic sector.
What This Means for Customers
With the receipt of the IVDR certification, all Class B products will now include:
- An updated Declaration of Conformity (DoC)
- New labels with the Notified Body number
- Updated Instructions for Use (IFU)
Commitment to Ongoing Support
Institut Virion\Serion GmbH is committed to providing timely updates and documentation to support customers in their registration and compliance processes. Customers in need of updated IVDR documentation are encouraged to reach out to the company to ensure smooth registration and product updates.
For more details, or to access the official certificate, visit Quality and Certificates.
Institut Virion\Serion GmbH continues to lead the way in In Vitro Diagnostics, ensuring that the highest standards of quality and regulatory compliance are met across the industry.