Guidance

Reporting adverse incidents: coronary stents

For manufacturers reporting adverse incidents with coronary stents under the European vigilance system.

Document

European Commission's guidance on reporting incidents with coronary stents and associated delivery systems

Details

MHRA’s guidance on when to report adverse incidents with coronary stents has been superseded by the European Commission’s guidance.

You need to read this alongside the European Commission’s guidelines on the vigilance system for medical devices.

Published 1 January 2014
Last updated 4 October 2016 + show all updates
  1. MHRA’s guidance on when to report adverse incidents with coronary stents has been superseded by the European Commission’s guidance. We have updated our links accordingly.
  2. First published.