Post-market surveillance of in vitro diagnostics

Overview

The purpose of post-market surveillance is to protect individual health and public health through continued surveillance of IVDs once they are placed on the market by reducing any risks. Such activities should ensure the manufacturer’s obligations are fulfilled through ensuring they are aware of event which enables them to undertake and assessment of any risks, and as appropriate any suggested steps to risk mitigation.

In the context of the WHO Prequalification of In Vitro Diagnostics Programme, this guidance aims to ensure the ongoing compliance of WHO prequalified IVDs with WHO prequalification requirements once they are placed on the market. Manufacturers of WHO prequalified IVDs are obliged to report regularly post-market information to the relevant national regulatory authorities, and to WHO.