临床上市后承诺.doc

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 up in the document. Therefore, this document reflects positions taken by representatives of interested parties in the medical devices sector. 该指南是在实施欧盟医疗器械指令过程中所遇到问题的系列指南中的一个，这些指南与指令之间没有法律效力的关联，这些指南是在通过对利益相关方（包括主管当局、委员会服务机构、行业以及其他利益相关各方）进行详尽的征询后谨慎起草的。在这个过程中，草稿被传阅，相关的建议在文件中加以吸收。因此，该文件体现了医疗器械各相关方代表的立场。 Foreword : Rationale and Goals of PMCF This document is intended to be a guide for manufacturers and notified bodies on how to carry out PMCF in order to fulfill post market surveillance obligation according to point 3. 1 of annex II, point 3. of annex IV, point 3 of annex V, point 3.1 of annex VI or point 4 of annex VII of medical device directive (add ref. AIMDD) While clinical evidence is an essential element of the premarket conformity assessment process, it is important to recognize the limitations inherent to these premarket clinical investigations. The extent of the data that can be gathered in the premarket phase does not enable the manufacturer to detect infrequent complications or problems only apparent after widespread use, or /long term performance issues. As part of the manufacturer?s quality system, a program of appropriate post market surveillance is key to identifying and investigating risks associated with the use of medical devices placed on the market. 前言：PMCF的依据及目标 本文件的目的是为制造商以及公告机构开展PMCF提供指导，以满足医疗器械指令附录II3.1，附录IV3，附录V3，附录VI3.1或附录VII4所要求的上市后市场监督义务。 虽然临床证据是对