Register/Notify your MDD-Medical Devices and IVDD-In Vitro Diagnostic Medical Devices in Europe by CE Marking Specialists based in London/UK. Click here to get FREE Guide Now!

Guidelines on   medical devices vigilance system   FOREWORD CONTENTS 1. INTRODUCTION 2. FOR WHOM THESE GUIDELINES ARE WRITTEN 3. PURPOSE OF THE VIGILANCE SYSTEM 4. GENERAL PRINCIPLES 5. TYPES OF INCIDENT TO BE REPORTED BY MANUFACTURERS 6. MAKING AND RECEIVING AN INITIAL REPORT 7. PROCEDURE FOLLOWING THE INITIAL REPORT 8. OUTCOME OF AN INVESTIGATION AND FOLLOW-UP 9. REGISTER OF KEY TERMS APPENDICES 1. LIST OF COMPETENT AUTHORITIES FOR VIGILANCE 2. DEFINITIONS 3. SUGGESTED INCIDENT REPORT FORMATS 4. SIMPLIFIED FLOW CHART - ILLUSTRATION OF INCIDENTS TO BE REPORTED 5. EXAMPLES OF INCIDENTS TO REPORT 6. SIMPLIFIED FLOW CHART ILLUSTRATING THE REPORTING OF RECALLS 7. RELEVANT EXTRACTS FROM THE DIRECTIVES 8. SUGGESTED COMPETENT AUTHORITY REPORT FORMAT 9. DIAGRAM OF THE VIGILANCE SYSTEM back to top of this page Please click the following links to learn more about every CE-Marking-related European Union Directive, Guidelines to Directives, Frameworks of implementation of Directives, and Agreements on Mutual Recognition of conformity assessment between European Union and other countries such as USA, Japan, Canada, Australia, New Zealand and Israel:- What is CE marking (CE mark)? The CE marking logo (Free download CE mark logo) Download of the EC Rep symbol/logo CE Marking (CE mark) EU/EC Declaration of Conformity: definition and required content What is a manufacturer? What are the responsibilities of a manufacturer? Is the Own Brand Labeller or Private Labeller considered as the legal Manufacturer? Why is CE marking called "European passport"? Does my product need CE Marking in order to be sold/exported on/to the European Market? How to obtain CE Marking for my product? How can Wellkang Tech Consulting help me to obtain CE Marking for my product? Wellkang can be your Authorized Representative in Europe for CE Marking purpose ! Complete list of all CE Marking Directives and Guidelines to Directives Complete list of all (more than 1000) Notified Bodies for CE marking Complete list of all European and/or international standards related to CE marking 85/374/eec: Directive of Liability for Defective Products (for all products) 1999/34/ec: Directive of Liability for Defective Products (amending) (for all products) 2000: (Proposal for a new) General Products Safety Directive (for all products) 92/59/eec: Directive of General Products Safety (for all products) 93/68/eec: "CE Marking" Directive (for all products) 93/465/eec: Conformity Assessment Procedures & CE Marking Rules, & Annex (for all products) Guide to Implementation of directives based on new approach & global approach (for all products) 73/23/eec: Directive of Low Voltage Electrical Equipment Guideline to Low Voltage Directive (LVD) 73/23/eec & Annex I, II 2000&2001 Framework of implementation of (LVD) Directive 73/23/eec 87/404/eec: Directive of Simple Pressure Vessels 88/378/eec: Directive of Toys & Annex I, II, ... IV 89/106/eec: Directive of Construction Products 89/336/eec: Directive of Electromagnetic Compatibility (EMC) Guideline to Directive of Electromagnetic Compatibility (EMC) 89/336/eec Communication 2000 in framework of implementation of EMC Directive 89/336/EEC 89/686/eec: Directive of Personal Protective Equipment (PPE) 90/384/eec: Directive of Non-automatic Weighing Instruments 90/396/eec: Directive of Appliances Burning Gaseous Fuels (AppliGas) 2001 Commission Communication in Framework of Impl (AppliGas) Directive 90/396/eec 92/42/eec: Directive of Efficiency of (Liquid or Gaseous fueled) Hot Water Boilers 93/15/eec: Directive of Explosives for Civil Uses 93/42/eec: Directive of Medical Devices 2001 Guidelines for Classification of Medical Devices Guidelines relating to the demarcation between Directives 90/385/eec, 93/42/eec and 65/65/eec. 90/385/eec: Directive of Active Implantable Medical Devices 98/79/ec: Directive of In Vitro Diagnostic Medical Devices Guidelines to Medical Devices Vigilance System List of Harmonised (European) Standards for Medical Devices List of Notified Bodies for Medical Devices Directive 93/65/eec: Directive of Air Traffic Management Equipment & Systems 94/9/ec: Directive of Equipment used in Potentially Explosive Atmospheres (Atex) Guidelines to directive 94/9/ec (Atex) 94/25/ec: Directive of Recreational Craft 95/16/ec: Directive of Lifts 96/48/ec: Directive of Trans-European High-speed Rail System 96/57/ec: Directive of Energy Efficiency: Household Refrigerators & Freezers 96/98/ec: Directive of Marine Equipment 98/37/ec: Directive of Machinery 2000: Comments on Directive of Machinery 98/37/ec 99/5/ec: Directive of Radio Equipment & Telecommunications Terminal Equipment (R&TTE) 2000/9/ec: Directive of Cableway Installations to Carry Persons 2000/14/ec: Directive of Noise Emission in the environment by equipment for use outdoors   | home/first page | back to where you were | back one page | top of this page | next page |