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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Details

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.

Updates to this page

Published 26 January 2015
Last updated 15 January 2025 show all updates

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

  2. Updated due to the end of the transition period.

  3. First published.

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