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What is IVDR?

The In Vitro Diagnostic Regulation (IVDR, EU 2017/746) is the new gold standard for diagnostic safety, performance and quality in Europe. In force since May 2022, IVDR raises the bar by requiring stronger clinical evidence, stricter risk classification, and enhanced traceability for every in vitro diagnostic (IVD) product.

From lab to patient - How does it affect me?

For manufacturers: IVDR demands, state of the art technology, robust clinical data, advanced quality systems, and closer oversight from Notified Bodies—driving innovation and ensuring only reliable, clinical significant, high-performance tests reach the market.

For buyers and laboratories: It offers peace of mind. Products are IVDR compliant, come with clear documentation, manufactured in certified quality facilities, trusted performance and improving service quality. IVDR has introduced a global database to give assurance that the device you are purchasing has been certified by a notified body.

For patients and clinicians: IVDR means greater confidence in every test result. With stricter post-market surveillance, lifecycle management and traceability, clinicians receive help from diagnostics that are not only innovative but also proven to be safe and effective.

  • IVDR Registered
  • In Application
  • Discontinued
Certificate NumberProduct NameCatalogue NumberClassificationClassification RuleEMDN CodeGrouping per CE Certificate
IVDR 803746BNP CONTROLS FOR BECKMAN (BNP CONTROL)CQ10520Class C (not self-test/near patient test/companion diagnostic) Rule 3gW01021301Class C W0102 IVP 3007
IVDR 803746BNP CONTROLS FOR ABBOTT (BNP CONTROL)CQ10521Class C (not self-test/near patient test/companion diagnostic) Rule 3gW01021301Class C W0102 IVP 3007
IVDR 803746BNP CONTROLS FOR SIEMENS (BNP CONTROL)CQ10522Class C (not self-test/near patient test/companion diagnostic) Rule 3gW01021301Class C W0102 IVP 3007
IVDR 803746Evidence MultiSTAT Drugs of Abuse (DOA) ToxPlex Urine ArrayEV4505Class C (not self-test/near patient test/companion diagnostic) Rule 3jW0102090199Class C W0102 IVP 3007
IVDR 803746ConcizuTraceTM ELISA (CZM)CZM10591Class C (not self-test/near patient test/companion diagnostic) Rule 3jW01020899Class C W0102 IVP 3007
IVDR 803746Ultra-Low PSA Control (UL PSA Control)TU10523Class C (not self-test/near patient test/companion diagnostic) Rule 3hW0102152005Class C W0102 IVP 3007
IVDR 803746Pre-eclampsia Control Level 1 (Pre-eclampsia CONTROL 1)PE10527Class C (not self-test/near patient test/companion diagnostic) Rule 3jW01021521Class C W0102 IVP 3007
IVDR 803746Pre-eclampsia Control Level 2 (Pre-eclampsia CONTROL 2)PE10528Class C (not self-test/near patient test/companion diagnostic) Rule 3jW01021521Class C W0102 IVP 3007
IVDR 803746Pre-eclampsia Control Level 3 (Pre-eclampsia CONTROL 3)PE10529Class C (not self-test/near patient test/companion diagnostic) Rule 3jW01021521Class C W0102 IVP 3007
IVDR 803746Type 1 Diabetes (T1D) SNP ArrayEV4489A/BClass C (not self-test/near patient test/companion diagnostic) Rule 3iW010699Class C W0106 IVP 3011
IVDR 803746SERUM BONE MARKER LEVEL 1 CONTROL (SERUM BONE MARKER CONTROL 1) SBM10574Class B (not self-test/near patient test/companion diagnostic) Rule 6W0102152099Class B IVR 0608
IVDR 803746SERUM BONE MARKER LEVEL 2 CONTROL (SERUM BONE MARKER CONTROL 2) SBM10587Class B (not self-test/near patient test/companion diagnostic) Rule 6W0102152099Class B IVR 0608
IVDR 803746SERUM BONE MARKER LEVEL 3 CONTROL (SERUM BONE MARKER CONTROL 3) SBM10588Class B (not self-test/near patient test/companion diagnostic) Rule 6W0102152099Class B IVR 0608
IVDR 803746Aldolase and Glutathione Reductase Calibrator (ALS & GLUT RED CAL)AGR10571Class B (not self-test/near patient test/companion diagnostic) Rule 6W0101050301Class B IVR 0608
IVDR 803746Aldolase and Glutathione Reductase Level 2 Control (ALS & GLUT RED CONTROL 2) AGR10572Class B (not self-test/near patient test/companion diagnostic) Rule 6W0101050101Class B IVR 0608
IVDR 803746Aldolase and Glutathione Reductase Level 3 Control (ALS & GLUT RED CONTROL 3) AGR10589Class B (not self-test/near patient test/companion diagnostic) Rule 6W0101050101Class B IVR 0608
IVDR 803746Evidence MultiSTAT TestosteroneEV4513Class B (not self-test/near patient test/companion diagnostic) Rule 6W0102050110Class B IVR 0608
IVDR 803746Evidence MultiSTAT Testosterone ControlEV4532Class B (not self-test/near patient test/companion diagnostic) Rule 6W0102152002Class B IVR 0608
IVDR 803746Evidence MultiSTAT SHBGEV4514Class B (not self-test/near patient test/companion diagnostic) Rule 6W0102050109Class B IVR 0608
IVDR 803746Evidence MultiSTAT SHBG ControlEV4533Class B (not self-test/near patient test/companion diagnostic) Rule 6W0102152002Class B IVR 0608
IVDR 803746XANTHOCHROMIA NEGATIVE CONTROL (XANTHOCHROMIA Negative Control) XN10502Class B (not self-test/near patient test/companion diagnostic) Rule 7W0101050102Class B IVR 0701
IVDR 803746XANTHOCHROMIA POSITIVE CONTROL (XANTHOCHROMIA Positive Control) XN10505Class B (not self-test/near patient test/companion diagnostic) Rule 7W0101050102Class B IVR 0701
IVDR 803746IMMUNOASSAY CONTROL - LEVEL 1 (IA CONTROL 1)LIA5142Class B (not self-test/near patient test/companion diagnostic) Rule 7W0101050102Class B IVR 0701
IVDR 803746IMMUNOASSAY CONTROL - LEVEL 2 (IA CONTROL 2)LIA5143Class B (not self-test/near patient test/companion diagnostic) Rule 7W0101050102Class B IVR 0701
IVDR 803746IMMUNOASSAY CONTROL - LEVEL 3 (IA CONTROL 3)LIA5144Class B (not self-test/near patient test/companion diagnostic) Rule 7W0101050102Class B IVR 0701
IVDR 803746Low Osmolality ControlUC10650Class B (not self-test/near patient test/companion diagnostic) Rule 7W0101050299Class B IVR 0701