ISO/AWI TS 16766

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

Scope

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.