Demonstration of scientific validity

Scientific validity means the demonstration of an association of an analyte with a clinical condition or a physiological state. Usually, the association has already been scientifically proven, but this must be documented as required by IVDR, Annex XIII:

The manufacturer demonstrates the scientific validity based on one or a combination of the following sources:
  • relevant information on the scientific validity of devices measuring the same analyte or marker;
  • scientific (peer-reviewed) literature;
  • consensus expert opinions/positions from relevant professional associations;
  • results from proof of concept studies;
  • results from clinical performance studies.

Right from the start

Already in the initial phase of a device’s development, a systematic literature research in scientific databases should be conducted to prove the scientific validity.

Objective of literature research

On the one hand literature research serves to ensure that known risks of similar products on the market may be excluded for your device; on the other hand it clearly reveals the present state of the art for your technology. These search results are then seamlessly integrated into your product development requirements. You are already familiar with possible comparable products as well as available clinical data. During the course of the further development process, a performance evaluation is prepared and filed as a central document for technical documentation; it is an obligatory prerequisite for CE marking.
Do you have questions about the interaction of analytical performance, clinical performance and scientific validity? Would you like to find out in more detail how these three are incorporated into performance evaluation? Don’t hesitate to contact us. We are happy to answer all your questions.

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