MDD指南,MEDDEV 2.12-1 rev.8-2013.01, 医疗器械警戒系统指南

EUROPEAN COMMISSION

DG Health and Consumers (SANCO)

Directorate B-Consumer Affairs

Unit B2- Health Technology and Cosmetics

MEDICAL DEVICES: Guidance document

The present guidelines are part of a set of guidelines relating to questions of application of EC-Directives on MEDICAL DEVICEs. They are legally not binding. The guidelines have been carefully drafted through a process of intensive consultation of the various interested parties (competent authorities, Commission services, industries, other interested parties) during which intermediate drafts were circulated and comments were taken up in the document. Therefore, this document reflects positions taken by representatives of interested parties in the MEDICAL DEVICEs sector.

Revision 8 of MEDDEV 2.12-1 explicitly includes IVF/ART devices within the scope of the vigilance system and provides clarity in relation to devices that are not intended to act directly on the individual. The revised guidance will be applicable as of July 2013.

ABLE OF ONTENTSTABLE OF CONTENTS ................................................................................................................................. 2

1 FOREWORD .................................................................................................................................... 4

2 INTRODUCTION .............................................................................................................................. 4

3 SCOPE ............................................................................................................................................. 5

3.1 GENERAL PRINCIPLES ...................................................................................................... 6

3.1.1 FOR MANUFACTURERS .................................................................................................. 6

3.1.2 FOR MANUFACTURERS OF DEVICES THAT ARE NOT INTENDED TO ACT

DIRECTLY ON THE INDIVIDUAL ...................................................................................... 7

3.1.3 FOR NATIONAL COMPETENT AUTHORITIES ................................................................ 7

3.1.4 FOR USERS ....................................................................................................................... 8

4 DEFINITIONS ................................................................................................................................... 8

4.1 ABNORMAL USE ................................................................................................................. 8

4.2 AUTHORISED REPRESENTATIVE ..................................................................................... 8

4.3 CORRECTIVE ACTION ........................................................................................................ 9

4.4 DRUG / DEVICE COMBINATION PRODUCT ...................................................................... 9

4.5 EUDAMED............................................................................................................................. 9

4.6 FIELD SAFETY CORRECTIVE ACTION (FSCA) ................................................................ 9

4.7 FIELD SAFETY NOTICE (FSN) .......................................................................................... 10

4.8 HARM .................................................................................................................................. 11

4.9 IMMEDIATELY .................................................................................................................... 11

4.10 INCIDENT ............................................................................................................................ 11

4.11 INDIRECT HARM ................................................................................................................ 11

4.12 INTENDED PURPOSE ........................................................................................................ 12

4.13 MANUFACTURER .............................................................................................................. 12

4.14 MEDICAL DEVICE .............................................................................................................. 12

4.15 OPERATOR ........................................................................................................................ 12

4.16 PERIODIC SUMMARY REPORTING ................................................................................. 12

4.17 SERIOUS PUBLIC HEALTH THREAT ............................................................................... 13

4.18 TREND REPORTING .......................................................................................................... 13

4.19 UNANTICIPATED ............................................................................................................... 13

4.20 USE ERROR ....................................................................................................................... 13

4.21 USER ................................................................................................................................... 13

5 MANUFACTURERS´ ROLE .......................................................................................................... 13

5.1 INCIDENT REPORTING SYSTEM ..................................................................................... 13

5.1.1 CRITERIA FOR INCIDENTs TO BE REPORTED BY MANUFACTURERS TO

COMPETENT AUTHORITIES .......................................................................................... 14

5.1.2 CONDITIONS FOR PERIODIC SUMMARY REPORTING UNDER THE MEDICAL

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