MEDDEV-2.12.2rev2Post-Market-Clinical-Follow-up-studies上市后临床跟踪中英文.pdfVIP

MEDDEV2.12/2rev2

January2012

GUIDELINESONMEDICALDEVICES关于医疗设备指导方针

POSTMARKETCLINICALFOLLOW-UPSTUDIES药品上市后临床跟踪研究

AGUIDEFORMANUFACTURERSANDNOTIFIEDBODIES指导生产商和相关人员

Note注释

ThepresentGuidelinesarepartofasetofGuidelinesrelatingtoquestionsofapplication本准则是有关欧共体指令对医疗器械的应用问题指引的一部分。其在法律上不具约

ofEC-DirectivesonmedicalDevices.Theyarelegallynotbinding.TheGuidelineshave束力。该指引通过对利益相关方（主管机构，委员会服务机构，行业人员，其他

beencarefullydraftedthroughaprocessofintensiveconsultationofthevariousinterest利益相关各方）进行详尽征询后审慎起草的。期间，中期草案经传阅，相关建议也

parties(competentauthorities,Commissionservices,industries,otherinterestedparties)收录在文档中。因此，该文件体现了医疗器械各相关方代表的立场。

duringwhichintermediatedraftswherecirculatedandcommentsweretakenupinthe

document.Therefore,thisdocumentreflectspositionstakenbyrepresentativesof

interestpartiesinthemedicaldevicessector.

CONTENTS目录

Introduction介绍

Scope范围

References参考文献

Definitions定义

Circumstanceswhereapostmarketclinicalfollowupstudyinindicated上市后临床跟踪研究所指环境

Elementsofapost-marketclinicalfollowupstudy上市后临床跟踪研究原理

Theuseofstudydata研究数据的用法

Theroleofthenotifiedbodyinpost-m