GHTF - Medical device labelling guidance

• Date: October 04, 2010
• Source: www.ghtf.org

This document provides guidance to manufacturers and Regulatory Authorities on medical device labelling that clearly informs the user of:

• its identity and intended use/purpose;
• how it should be used, maintained and stored;
• any residual risks, warnings or contra-indications;

Also it promotes

• labelling commensurate with the technical knowledge, experience, education or training of intended users;
• use of symbols.
• the avoidance of prescriptive country-specific requirements for labelling text, content, or the format of labels or labelling that offer no user or patient benefit

Sections:

Definitions
Labelling Requirements
 - General Principles
 - Content of Labelling

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