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ISO/CD TS 16766.2

Manufacturers’considerations for in vitro diagnostic medical devices in a public health crisis ISO/CD TS 16766.2

General information

30.60 Close of voting/ comment period   Apr 12, 2024

ISO

ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems

Technical Specification

11.100.10   In vitro diagnostic test systems

Scope

This document provides guidance to manufacturers on the minimal considerations for in vitro diagnostic (IVD) medical devices in a public health crisis:
- general considerations;
- risk reduction;
- monitoring the devices’ post-market performance and quality assurance;
- implementing a communication system.
This document does not supersede the existing traditional regulatory authorization requirements for IVD medical devices available in the marketplace.

Life cycle

NOW

IN_DEVELOPMENT
ISO/CD TS 16766.2
30.60 Close of voting/ comment period
Apr 12, 2024