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/DTS 16766 50.20
Proof sent to secretariat or FDIS ballot initiated: 8 weeks 27 gush 2024
Preview
Only informative sections of projects are publicly available. To view the full content, you will need to members of the committee. If you are a member, please log in to your account by clicking on the "Log in" button.
English