GHTF SG1 - International Medical Device Regula..doc

SG1/N011R17PROPOSED DOCUMENTGlobal Harmonization Task ForceTitle: Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)Authoring Group: Study Group 1 of the Global Harmonization Task ForceDate: October 25, 2002Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)Study Group 1 Proposed Document SG1/N011R17October 25, 2002 Page 2 of 20Table of ContentsPreface .................................................................................................................................31.0 Introduction..............................................................................................................................42.0 Scope........................................................................................................................................43.0 References................................................................................................................................54.0 Definitions ...............................................................................................................................65.0 Intended use of the STED and its preparation .........................................................................76.0 Format for Summary Technical Documentation .....................................................................86.1 Basic Format 86.2 How to Apply the Basic Format when a Pre-market Submission is not Required 96.3 How to Apply the Basic Format when a Pre-market Submission is Required 97.0 Guidance on the Elements of the STED ................................................................................107.1 Relevant Essential Principles and Method Used to Demonstrate Conformity107.1.1 General.......................................................................................................................107.1.2 Essential Principles and Evidence of Conformity .....................................................107.2 Device Description 107.2.1 General Information...................................................................................................107.2.2 Materials ....................................................................................................................117.2.3 Specifications.............................................................................................................117.2.4 Other Descriptive Information...................................................................................117.3 Summary of Design Verification and Validation Documents 117.3.1 General.......................................................................................................................117.3.2 Clinical Evidence.......................................................................................................127.4 Labelling 127.5 Risk Analysis 137.6 Manufacturer Information 13Appendix A1: The Relationship of the STED to the Work of GHTF Study Groups 2, 3 & 4 .....................................................................................................................................14Appendix A2: Decision Process to Determine Whether to Use the STED .......................15Appendix B: Example of an Essential Principles Conformity Checklist ..........................16Appendix C: Additional Recommendations for STEDs provided to regulatory authorities for review/approval..........................................................................................18Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)Study Group 1 Proposed Document SG1/N011R17October 25, 2002 Page 3 of 20PrefaceThis document was produced by the Global Harmonization Task Force, a voluntary consortium of representatives from medical device Regulatory Authorities and Trade Associations from around the world. The document is intended to provide non-binding guidance to Regulatory Authorities for use in the regulation of medical devices and has been subject to consultation throughout its development and endorsement by the current Chair. Endorsement by the Chair signifies acceptance by consensus amongst members of the GHTF Steering Committee, as a document to be promoted by all members of the GHTF. The primary way in which the Global Harmonization Task Force (GHTF) achieves its goals is through the production of harmonized guidance documents suitable for implementation or adoption by member Regulatory Authorities or by nations with developing regulatory programmes.There are no restrictions on the reproduction, distribution, translation or use of this document however, incorporation of this document, in part or in whole, into any other document does not convey or represent an endorsement of any kind by the Global Harmonization Task Force.@n。