GHTF SG1 - International Medical Device Regula..DOCVIP

SG1/N011R17 PROPOSED DOCUMENT Global Harmonization Task Force Title: 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 Force Date: October 25, 2002 Table of Contents Preface 3 1.0 Introduction 4 2.0 Scope 4 3.0 References 5 4.0 Definitions 6 5.0 Intended use of the STED and its preparation 7 6.0 Format for Summary Technical Documentation 8 6.1 Basic Format 8 6.2 How to Apply the Basic Format when a Pre-market Submission is not Required 9 6.3 How to Apply the Basic Format when a Pre-market Submission is Required 9 7.0 Guidance on the Elements of the STED 10 7.1 Relevant Essential Principles and Method Used to Demonstrate Conformity 10 7.1.1 General 10 7.1.2 Essential Principles and Evidence of Conformity 10 7.2 Device Description 10 7.2.1 General Information 10 7.2.2 Materials 11 7.2.3 Specifications 11 7.2.4 Other Descriptive Information 11 7.3 Summary of Design Verification and Validation Documents 11 7.3.1 General 11 7.3.2 Clinical Evidence 12 7.4 Labelling 12 7.5 Risk Analysis 13 7.6 Manufacturer Information 13 Appendix A1: The Relationship of the STED to the Work of GHTF Study Groups 2, 3 4 14 Appendix A2: Decision Process to Determine Whether to Use the STED 15 Appendix B: Example of an Essential Principles Conformity Checklist 16 Appendix C: Additional Recommendations for STEDs provided to regulatory authorities for review/approval 18 Preface This 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.