Codes & Standards - Purchase
ISO/TS 16766:2024
Manufacturers’ considerations for in vitro diagnostic medical devices in a public health emergency
SKU: iso_084816_189740
Published by ISO
Publication Year 2024
1 Edition
13 pages
Product Details
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.
