Summary:
Bio-Rad Laboratories has achieved the EU Quality Management Systems Certificate under IVDR, allowing CE Marking of 40 Exact Diagnostics-branded infectious disease molecular quality controls, with the remaining products awaiting certification.

Takeaways:

  1. The IVDR certification enables Bio-Rad to continue supplying CE-marked products to the EU market during and after the IVDR transition.
  2. The new IVDR framework requires an accredited notified body’s involvement, unlike the previous self-certification process.
  3. Exact Diagnostics’ molecular quality controls are formulated with whole organisms to simulate patient specimens, aiding in ISO 15189:2022 compliance and reducing costs and waste.

Bio-Rad Laboratories, a global provider of life science research and clinical diagnostics products, has received the EU Quality Management Systems Certificate under IVDR (Regulation (EU) 2017/746), enabling the CE Marking of 40 Exact Diagnostics-branded infectious disease molecular quality controls under IVDR. The remaining controls in the portfolio will be submitted soon for certification.

Under the previous EU regulatory framework (IVD Directive 98/79/EC), manufacturers were permitted to self-certify most of their QC products. However, with the introduction of the IVDR regulations, involvement of an accredited notified body is required. 

IVDR Certification Demonstrates Commitment to Quality

Achieving IVDR certification demonstrates a strong commitment to quality and ensures that IVDR CE Marked products can continue to be offered to the EU market throughout the IVDR transition period and beyond.

The products that can now be CE Marked under IVDR include:

·         Adenovirus High and Low Run Controls (ADVH102 and ADVL101)

·         Anaplasma Run Control (ANARC)

·         Babesia Run Control (BABRC)

·         Bartonella Run Control (BRTRC)

·         BKV High and Low Run Controls (BKVH102 and BKVL101)

·         Borrelia Run Control (BORRC)

·         CMV High and Low Run Controls (CMVH102 and CMVL101)

·         CT/NG Positive Run Control and STI Negative Control (CTNGPOS and NEGSTI)

·         EBV High and Low Run Controls (EBVH102 and EBVL101)

·         Ehrlichia Run Control (ERLRC)

·         Enterovirus Run Control (EVRC)

·         HHV-6 High and Low Run Controls (HV6H102 and HV6L101)

·         HPV Genotype 16, 18, 68 Controls and HPV Negative (HPV16C, HPV18C, HPV68C and HPVNEG)

·         HSV-1 High and Low Run Controls (HSV1H102 and HSV1L101)

·         HSV-2 High and Low Run Controls (HSV2H102 and HSV2L101)

·         JCV High and Low Run Controls (JCVH102 and JCVL101)

·         Parvovirus B19 High and Low Run Controls (B19H102 and B19L101)

·         Respiratory (RP) Positive and Negative Controls (RPPOS and RPNEG)

·         SARS-CoV-2 Positive and Negative Run Controls (COV019CE and COV000CE)

·         SARS-CoV-2, Flu, RSV Positive and Negative Run Controls (COVFLU and COVFLUNEG)

·         VZV High and Low Run Controls (VZVH102 and VZVL101)

·         ZKV High and Low Run Controls (ZKVH102 and ZKVL101)

The CT/NG Positive Run Control (CTNGPOS) and STI Negative Run Control (NEGSTI) will be the first products to be CE-Marked under IVDR, with an estimated market release at the end of Q1 2025. The remaining products will follow thereafter.

Formulated with Whole Organisms

The Exact Diagnostics-branded molecular quality controls are formulated with whole organisms in relevant matrices to simulate patient specimens. This design ensures that those controls undergo the same workflow and process challenges as patient specimens during routine testing. These attributes support laboratories’ compliance with the ISO 15189:2022 guidelines.

These controls allow multiple uses, reducing both costs and waste. Each positive control can be paired with a corresponding negative control. Those controls are available in the Exact Diagnostics product portfolio.

Featured Image: Bio-Rad Laboratories, a global provider of life science research and clinical diagnostics products, has received the EU Quality Management Systems Certificate under IVDR (Regulation (EU) 2017/746), enabling the CE Marking of 40 Exact Diagnostics-branded infectious disease molecular quality controls under IVDR. Photo: Bio-Rad