文档介绍：MEDDEV212-(SANCO)DirectorateB-ConsumerAffairsUnitB2-HealthTechnologyandCosmeticsMEDICALDEVICES:-1rev8January2013GUIDELINESONAMEDICALDEVICESVIGILANCESYSTEMThepresentguidelinesarepartofasetofguidelinesrelatingtoquestionsofapplicationofEC-,industries,otherinterestedparties),-1explicitlyincludesIVF/-.................................................................................................................................21FOREWORD....................................................................................................................................42INTRODUCTION..............................................................................................................................43SCOPE..................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................84DEFINI