ISO/DTS 16766

This draft is in the approval phase.

Abstract

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.

General information

Status
: Under development

Stage
: Final text received or FDIS registered for formal approval [50.00]
Edition
: 1
Technical Committee :
ISO/TC 212

ICS :
11.100.10
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