Adverse incidents: in vitro diagnostic (IVD) blood glucose meters
- Medicines and Healthcare products Regulatory Agency
- Part of:
- Medical devices: guidance for manufacturers on vigilance, Patient safety, Medical devices regulation and safety, and Vigilance, safety alerts and guidance
- 26 January 2015
For manufacturers reporting adverse incidents with IVD blood glucose meters under the European vigilance system.
PDF, 53KB, 2 pages
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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