In vitro diagnostics and laboratory technology

In vitro diagnostics laboratory evaluation

Laboratory evaluation of the product occurs following a successful review of the product dossier. The laboratory evaluation to assess the operational and performance characteristics of the product is carried out by an evaluation site.

laboratory technician performing a diagnostic test

Irrespective of if the product meets WHO prequalification requirements or does not, a summary of the laboratory evaluation report will be published in a WHO composite report as part of the WHO technical series on the performance and operational characteristics of commercially available IVDs.