ISO/TS 16766:2024
Manufacturersâ considerations for in vitro diagnostic medical devices in a public health emergency
détails du produit
NOTEÂ Â Â Â Â Â Â Â Â Â Â 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:
â                  following a risk management process;
â                  monitoring the deviceâs post-market performance and quality assurance;
â                  implementing a communication system.