MEDDEV-2.12-2上市后临床跟踪指南.pdfVIP

EUROPEAN COMMISSION DGENTERPRISE DirectorateG Unit 4-PressureEquipment,MedicalDevices,Metrology MEDICAL DEVICES:Guidancedocument MEDDEV 2.12-2 May 2004 GUIDELINESON POSTMARKETCLINICALFOLLOW-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 aprocess of intensive consultation of the variousinterested parties (competent authorities, Commission services, indu