Post-market surveillance of in vitro diagnostics (2015)




English version published in 2015, Russian version in 2018.

Post-market surveillance aims to ensure that in vitro diagnostics (IVDs) continue to meet the same quality, safety and performance requirements as when they were initially placed on the market. Post-market surveillance consists of reactive post-market surveillance after an issue has occurred related to the IVD, and proactive post-market surveillance to scan for potential issues related to the IVD.

These guidelines describe the measures that should be taken to ensure the ongoing compliance of WHO-prequalified IVDs with WHO prequalification requirements for safety, quality and performance after they are placed on the market. Therefore, manufacturers, end users of IVDs in laboratories and other testing sites;, and regulators of WHO prequalified IVDs are suggested to follow this guidance.

However, in light of the current lack of adequate post-market surveillance in many settings, the principles of this guidance may also be applied to other IVDs (either analyte or format) that fall outside the scope of the WHO Prequalification of In Vitro Diagnostics Programme.