Publication

PD ISO/TS 16766:2024

Manufacturers’ considerations for in vitro diagnostic medical devices in a public health emergency

Current

•

Published:

30 Nov 2024

1 Scope

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.

Product Details

Descriptors

Diagnostic equipment (medical)

Diagnostic instruments (medical)

Laboratory equipment

Medical equipment

Medical laboratory equipment

ICS Codes

11.100.10 In vitro diagnostic test systems

Committee

CH/212

International relationships

Identical to:

ISO/TS 16766

ISBN

978 0 539 24592 9

Publisher

BSI