MEDICAL DEVICES: Guidance document
MEDDEV 2.12-1 rev 8 January 2013
GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM
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.
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 DEVICE VIGILANCE SYSTEM ........................................................................................ 16 5.1.2.1 INCIDENTS DESCRIBED IN A FIELD SAFETY NOTICE...................................... 16 5.1.2.2 COMMON AND WELL-DOCUMENTED INCIDENTS ............................................ 16 5.1.3 CONDITIONS WHERE REPORTING UNDER THE MEDICAL DEVICE VIGILANCE SYSTEM IS NOT USUALLY REQUIRED ........................................................................ 17 5.1.3.1 DEFICIENCY OF A DEVICE FOUND BY THE USER PRIOR TO ITS USE .......... 17 5.1.3.2 EVENT CAUSED BY PATIENT CONDITIONS ...................................................... 17 5.1.3.3 SERVICE LIFE OR SHELF-LIFE OF THE MEDICAL DEVICE EXCEEDED ......... 18 5.1.3.4 PROTECTION AGAINST A FAULT FUNCTIONED CORRECTLY ........................ 18 5.1.3.5 EXPECTED AND FORESEEABLE SIDE EFFECTS .............................................. 19 5.1.3.6 NEGLIGIBLE LIKELIHOOD OF OCCURRENCE OF DEATH OR SERIOUS DETERIORATION IN STATE OF HEALTH................................................................................ 20 5.1.4 TREND REPORTS ........................................................................................................... 20 5.1.5 REPORTING OF USE ERROR AND ABNORMAL USE .................................................. 21 5.1.5.1 REPORTABLE USE ERRORS ............................................................................... 21 5.1.5.2 USE ERROR WHERE REPORTING UNDER THE MEDICAL DEVICE VIGILANCE SYSTEM IS NOT USUALLY REQUIRED. ................................................................................. 21 5.1.5.3 CONSIDERATION FOR HANDLING ABNORMAL USE ........................................ 21 2