Guidance

Adverse incidents: cardiac ablation catheters

For manufacturers reporting adverse incidents with cardiac ablation catheters under the European vigilance system.

Documents

European Commission’s Cardiac Ablation Vigilance Reporting Guidance

Details

MHRA’s guidance on when to report adverse incidents with cardiac ablation catheters was superseded by the European Commission’s guidance in November 2014.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
Last updated 7 March 2016 + show all updates
  1. Amended guidance to indicate MHRA’s guidance was superseded by the European Commission’s guidance in November 2014.
  2. First published.