Guidance

Adverse incidents: in vitro diagnostic (IVD) blood glucose meters

For manufacturers reporting adverse incidents with IVD blood glucose meters under the European vigilance system.

Document

Adverse incidents with IVD blood glucose meters

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Details

Guidance on how to report adverse incidents with IVD blood glucose meters for point of care testing or home use. You need to read this alongside the European Commission’s guidelines on the vigilance system for medical devices.

Published 26 January 2015