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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