临床上市后承诺.docVIP

PAGE  PAGE 23 临床上市后承诺 篇一：MEDDEV 2.12-2上市后临床跟踪指南 EUROPEAN COMMISSION DG ENTERPRISE Directorate G GUIDELINES ON POST MARKET CLINICAL FOLLOW-UP 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