Adverse incidents: cardiac ablation catheters
- 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
- First published:
- 1 November 2008
- Last updated:
- 7 March 2016, see all updates
For manufacturers reporting adverse incidents with cardiac ablation catheters under the European vigilance system.
MHRA’s guidance on when to report adverse incidents with cardiac ablation catheters was superseded by the European Commission’s guidance in November 2014.
You need to read this alongside the European Commission’s guidelines on the vigilance system for medical devices.
Published: 1 November 2008
Updated: 7 March 2016
- Amended guidance to indicate MHRA’s guidance was superseded by the European Commission’s guidance in November 2014.
- First published.