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Scientific Validity

We help you to identify and review scientifically valid claims for the intended purpose. 

What does scientific validity mean?

As defined in Article 2 of the regulation IVDR 2017/746, scientific validity means “the association of an analyte with a clinical condition or physiological state”.  

To demonstrate scientific validity, the IVD manufacturer needs to use 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 identified through a systematic literature review.
  • Expert opinions/positions from relevant professional associations.
  • Results from proof of concept studies.
  • Results from clinical performance studies.

First, all information collected during this process serves to ensure that known risks of similar products on the market may be excluded for the in-development device. Furthermore, they clearly reveal the present state ofthe used technology. This scientific information should be clearly structured and well-documented in a scientific validity report integrated as a central document for technical documentation; it is a mandatory prerequisite for CE marking. 

How can Cerba Xpert support for producing Scientific Validity Plan and Report?

Cerba Xpert offers a complete and tailor-made service for Scientific Validity by: 

  • Identifying and reviewing  the scientific validity claims in the intended purpose.
  • Establishing the literature search plan.
  • Performing a systematic search and selection of peer-reviewed literature on each scientific validity claim.
  • Critically evaluating the literature and writing  the Scientific Validity Report (SVR) to be directly integrated into your technical documentation.
  • Performing a cycle of revisions with the customer to ensure that the SVR is properly established.
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Ensure your tool’s scientific validity together with our experts. 

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