MEDDEV 2.12-1 : REV 8 : 2013
Current
The latest, up-to-date edition.
GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM
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
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.
| DevelopmentNote |
Available for free download. (01/2017)
|
| DocumentType |
Standard
|
| Pages |
64
|
| ProductNote |
THIS STANDARD IS ALSO REFERS TO: EN ISO 9000:2000, EN IEC 60601-1-6
|
| PublisherName |
European Union
|
| Status |
Current
|
Please Login or Create an Account so you can add users to your Multi user PDF Later.
Important note : All end users must be registered with an Account prior to user licenses being assigned.
Users cannot be edited or removed once added to your Multi user PDF.