Résumé
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.
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État actuel: Projet
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Edition: 1
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- ICS :
- 11.100.10 Systèmes de diagnostic in vitro
Cycle de vie
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