This document provides guidance to manufacturers on the minimum requirements for the lifecycle management of in vitro diagnostic (IVD) medical devices that are developed in preparation for and in response to a public health emergency involving infectious agents requiring immediate availability of authorized IVD devices.
NOTE: This document does not replace existing national (or regional) regulatory pathway requirements for IVD medical devices under non-emergency situations. The regulatory authorization process of emergency use-IVD medical devices is country-specific and it includes:
— following a risk management process;
— monitoring the device’s post-market performance and quality assurance;
— implementing a communication system.
NOTE: This document does not replace existing national (or regional) regulatory pathway requirements for IVD medical devices under non-emergency situations. The regulatory authorization process of emergency use-IVD medical devices is country-specific and it includes:
— following a risk management process;
— monitoring the device’s post-market performance and quality assurance;
— implementing a communication system.
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