MEDDEV 2.12-1 : REV 8 : 2013

1 FOREWORD
2 INTRODUCTION
3 SCOPE
4 DEFINITIONS
5 MANUFACTURERS' ROLE
6 RESPONSIBILITIES OF NATIONAL COMPETENT
  AUTHORITY
7 THE ROLE OF THE NOTIFIED BODIES
8 THE ROLE OF THE COMMISSION
9 USERS ROLE WITHIN THE VIGILANCE SYSTEM
ANNEXES
ANNEX 1 - EXAMPLES OF INCIDENTs AND FIELD SAFETY
           CORRECTIVE ACTIONS WHICH THE MANUFACTURER
           SHOULD REPORT
ANNEX 2 - EXTRACTS FROM DIRECTIVES RELATING TO
           'MEDICAL DEVICES VIGILANCE'
ANNEX 3 - REPORT FORM FOR MANUFACTURER'S TO
           THE NATIONAL COMPETENT AUTHORITY
ANNEX 4 - REPORT FORM FOR FIELD SAFETY CORRECTIVE
           ACTION
ANNEX 5 - TEMPLATE FOR A FIELD SAFETY NOTICE
ANNEX 6 - MANUFACTURER'S PERIODIC SUMMARY REPORT
           FORM
ANNEX 7 - MANUFACTURER'S TREND REPORT FORM
ANNEX 8 - NATIONAL COMPETENT AUTHORITY REPORT
           FORMAT
ANNEX 9 - TITLES OF GLOBAL HARMONISATION TASK
           FORCE STUDY GROUP 2 DOCUMENTS USED IN
           THE DEVELOPMENT OF THIS MEDDEV AND/OR
           CITED
ANNEX 10 - LIST OF THE USED ABBREVIATIONS
ANNEX 11 - GUIDANCE TO MANUFACTURERS WHEN
           INVOLVING USERS IN THE VIGILANCE
           SYSTEM

Includes the actions to be taken once the MANUFACTURER or National Competent Authority receives information concerning an INCIDENT involving a MEDICAL DEVICE. Information on INCIDENTs which should be reported under the Medical Device Vigilance System may come to the attention of MANUFACTURERs via the systematic procedure to review experience gained from devices in the post-production phase, or by other means.