Normative guidance on post-market surveillance of in-vitro diagnostics

This document pertains to the objectives and processes of the post-market surveillance for IVDs that are within the scope of the WHO Prequalification of In Vitro Diagnostics Programme, i.e. WHO prequalified IVDs2 . It describes 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, users, and regulators of WHO prequalified IVDs are suggested to follow this guidance