What does scientific validity under IVDR mean and how is it proven?

Scientific validity refers to the association of an analyte with a specific clinical or physiological condition. The IVDR demands that this relationship is scientifically proven. Scientific publications, expert opinions, and results from analytical and clinical performance studies can be used for this purpose.

For your established products, proof of scientific validity can often already be provided by means of a systematic literature search and evaluation based on published data. But also, in the case of new product developments, a systematic literature search at an early developmental stage can be useful as basis for a performance evaluation in order to determine the risk profile of your IVD based on comparable products as well as to define the state of the art.

novineon CRO performs a systematic and methodologically sound literature evaluation for your IVD, which is specifically adapted to your requirements. The methodology of the literature search, the search protocol and the analysis of the literature data are summarized in a report. This includes a description of the methodology of the literature search, a literature search protocol, and a literature review report. The identified data are evaluated in the context of the medical background as well as the technical and scientific state of the art. This literature review forms the basis for the scientific validity report, which is also a fundamental pillar of the performance evaluation.

If you have any questions regarding a systematic literature review, please feel free to contact us at ivd@novineon.com.