MEDDEV2.122上市后临床跟踪指南VIP专享VIP免费

EUROPEAN COMMISSIONDG ENTERPRISEDirectorate GUnit 4 - Pressure Equipment, Medical Devices, MetrologyMEDICALDEVICES:GuidancedocumentMEDDEV 2.12-2May2004GUIDELINESON POSTMARKETCLINICALFOLLOW-UPThe present Guidelines are part of a set of Guidelines relating to questions of application ofEC-Directives on medical devices. They are legally not binding. The Guidelines have beencarefullydrafted through a process of intensive consultation of the various interested parties(competent authorities, Commission services, industries, other interested parties) duringwhich intermediate drafts were circulated and comments were taken up in the document.Therefore, this document reflects positions taken byrepresentatives of interested parties inthe 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 PMCFThis documentis intendedto be a guide for manufacturersandnotifiedbodies on how to carryoutPMCFin orderto fulfill post marketsurveillanceobligationaccordingto point 3.1 of annexII,point3.of annexIV, point3of annexV, point3.1of annexVI or point4 of annexVII of medicaldevice directive(addref.AIMDD)While clinical evidence is an essentialelementof the premarketconformityassessmentprocess,itis importantto recognizethe limitationsinherentto these premarketclinical investigations.Theextentof the datathatcan be gatheredin the premarketphasedoes not enablethe manufacturertodetect infrequentcomplicationsor problems only apparentafter widespreaduse, or /longtermperformanceissues. As partof the manufacturer’squalitysystem, a pr...