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. 

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.