Guidance

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

Device-specific guidance for manufacturers on reporting adverse incidents under the vigilance system.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 26 January 2015
• Last updated: 15 January 2025 — See all updates

Documents

Device-specific vigilance guidance: in vitro diagnostic (IVD) blood glucose monitors, covering point of care testing and home use

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Guidance for manufacturers reporting adverse incidents involving on IVD blood glucose monitors under the vigilance system.

To be read in conjunction with the guidelines on post market surveillance.

Published 26 January 2015

Last updated 15 January 2025 + show all updates

1. 15 January 2025

   Updated to reflect the laying of The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024.

2. 30 December 2020

   Updated due to the end of the transition period.

3. 26 January 2015

   First published.