Guidance

Reporting adverse incidents: insulin pumps and meter systems

How to report adverse incidents involving insulin infusion pumps and integrated meter systems under the vigilance system.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 15 January 2025

Documents

Device-specific vigilance guidance: insulin infusion pumps and integrated meter systems

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Guidance for manufacturers on reporting adverse incidents involving insulin infusion pumps and integrated meter systems under the vigilance system.

You should read this document should be in conjunction with guidance on post-market surveillance.