Is there an IVDR requirement that says your predicate must follow the most current WHO reference standard?

Mike W

The goal: To gain CE Mark for a quantitative test of a viral antigen.

  • Currently, there are ONLY 3 CE-marked assays from 3 different Manufacturers for the quant detection of this viral antigen.
  • The World Health Organization are currently on their 4th version of the international reference standard for this viral antigen (here is an example of the 2nd WHO int. standard for covid antibodies).
  • Only 1 of the 3 CE-Marked assays use this 4th version (the latest version) while the other assays used older versioins (2nd or 3rd) for their CLINICAL EVALUATION
  • Also, these assays gained CE mark before the IVDD-->IVDR

Finally back to the main question- Is there a rule in IVDR that states the predicate device we pick to evaluate clinical performance of our new quantitative test must use the most recent version of the WHO INTL reference standard?Does using an "older version" in our clinical evaluation violate IVDR requirement?

thank you so much, appreciate any input
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