Scientific validity in the PE before market launch (pre-market)

According to Annex XIII of the IVDR, manufacturers must demonstrate scientific validity using one of the following sources or combinations of these sources:

  • relevant information on the scientific validity of products for which the same analyte or marker is measured
  • scientific literature (which has been peer-reviewed)
  • consistent expert appraisals/expert statements from relevant specialist organizations
  • results from studies to prove the principle of action
  • results from clinical performance studies.

Biomex GmbH offers support with systematic literature research to confirm the scientific validity of an analyte. We also assist to evaluate literature searches according to specified criteria and to document them in a comprehensive manner so that they can be used to confirm the clinical performance of a product. Contact us!