Transcription of GHTF SG1 - Summary Technical Documentation (STED) for ...
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GHTF SG1 - Summary Technical Documentation (STED) for ...
GHTF/SG1/N063:2011 FINAL DOCUMENT Global Harmonization Task Force Title: Summary Technical Documentation ( sted ) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices Authoring Group: Study Group 1 of the Global Harmonization Task Force Date: March 17th, 2011 Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of IVD Medical Devices ( sted ) Study Group 1 Final Document GHTF/SG1/SG1/N063:2011 March 17th, 2011 Page 2 of 30 Table of Contents Rationale, Purpose and 6 6 Preparation and Use of the 8 The Use of the sted in the Premarket 9 The Use of the sted in the Post-market 11 The Use of the sted to Notify Changes to the 11 Device Description including Variants (Configurations) and Device 12 Reference to the Manufacturer s Previous Device Generation(s) and/or Similar Devices or Device 13 For an IVD medical device not yet available on any 13 For an IVD medical device already available on the market in any 13 Essential Principles ()
of information from the technical documentation to the STED is illustrated in Figures 1 and 2. It can be seen from these figures that the content of the STED is the same for both pre and post market use but the circumstances for the use of the STED are different. Where the STED is submitted to a RA/CAB, it should be in a language
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