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
  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.

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.