Guidance

Reporting adverse incidents: biological and mechanical surgical heart valves

For manufacturers reporting adverse incidents with biological/mechanical surgical heart valves under the vigilance system.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 1 January 2014
• Last updated: 30 December 2020 — See all updates

Documents

Artificial heart valves

PDF, 133 KB, 2 pages

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Details

Guidance on how to report adverse incidents with biological/mechanical surgical heart valves. To be read in conjunction with the guidelines on a medical devices vigilance system MEDDEV 2.12/1.

Published 1 January 2014

Last updated 30 December 2020 + show all updates

1. 30 December 2020

   This page has been updated due to the end of the transition period.

2. 1 January 2014

   First published.