Guidance
Adverse incidents: cardiac ablation catheters
For manufacturers reporting adverse incidents with cardiac ablation catheters under the European vigilance system.
Documents
Details
The European Commission’s guidance on when to report adverse incidents with cardiac ablation catheters (DSVG 01) was published in November 2014.
You need to read this alongside the European Commission’s guidelines on the vigilance system for medical devices.
These documents are on this Commission webpage under Guidance > Guidance MEDDEVs, 2.12 Post-market surveillance.
Updates to this page
Published 1 November 2008Last updated 7 March 2016 + show all updates
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Amended guidance to indicate MHRA’s guidance was superseded by the European Commission’s guidance in November 2014.
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First published.