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
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Status: Under developmentStage: Final text received or FDIS registered for formal approval [50.00]
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Edition: 1Number of pages: 13
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Technical Committee :ISO/TC 212ICS :11.100.10
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