MEDDEV 2.12-1 : REV 8 : 2013
Current
The latest, up-to-date edition.
Hardcopy
English
01-01-2013
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
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