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 Aug 27, 2024
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