Post-Market Clinical Follow-Up Studies - GHTF guidance

• Date: May 03, 2009
• Source: www.ghtf.org

This document provides guidance in relation to:

1. the circumstances where a post-market clinical follow-up study is indicated;
2. the general principles of post-market clinical follow-up studies involving medical devices; and
3. the use of study information, including, for example, to provide information to update labelling.

This document does not apply to in vitro diagnostic devices.

It explains -

• The Circumstances Where A Post-Market Clinical Follow-Up Study Is Indicated
• The Elements Of A Post-Market Clinical Follow-Up Study
• The Use Of Study Information

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