Transcription of EUROPEAN COMMISSION DG Health and Consumers (SANCO ...
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EUROPEAN COMMISSION DG Health and Consumers (SANCO ...
MEDDEV 2 12-1 rev. 8 Vigilance 1 EUROPEAN COMMISSION DG Health and Consumers (SANCO) Directorate B-Consumer Affairs Unit B2- Health Technology and Cosmetics MEDICAL DEVICES: Guidance document MEDDEV 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.
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
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