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WhoisMedNetGmbHisaGermanSalesandMarketingOrganizationofferingEuropeanAuthorizedRepresentationServiceworldwideOfferEARserivce:since1993Headquarter:Münster–GermanyOffices:UK,Israel,ChinaActivein...EuropeanCountriesWeareoneoftheLargestandFirstClassprovideroftheserviceinEurope1.Februar2020MedNet是谁?GmbH是一家德国公司。我们集销售和市场于一体，为世界各地的制造商提供欧盟授权代表服务。欧代服务:从1993年开始总部:德国——明斯特办事处:英国，以色列，中国活跃于：欧洲各国我们已经是欧洲最大，最一流的服务机构之一1.Februar20201.Februar2020•ProfessionalEARserviceforMedicalDevices•fastandprofessionalRegistration•supplyFreeSalesCertifcate•Legalizethedocumentsasyouneed~1000productregistrationsperformedfor3000products•MedNetisISO13485certified•MedNetunderstandsmedicaldevicesWeareFASTandCOSTEFFECTIVEMedNetAdvantages1.Februar2020•为医疗器械提供专业的欧盟授权代表服务•快速专业的产品注册•申请自由销售证明（FreeSalesCertifcate）•帮您给需要的文件办理认证已经为超过3000的产品，办理了约1000多个产品注册•MedNet拥有ISO13485认证•MedNet熟悉医疗器械和相关欧盟法规我们速度更快而且为您节省费用MedNet的优势1.Februar2020Inthispresentationwediscuss,whathappensafterhavingreceivedtheCE-mark在这里，我们将讨论：拿到CE标志后，会发生什么Topics1.Februar2020Wewillcoverthefollowingtopics:•WhatisanEC-Representative•ProductregistrationissuesinEurope•FreeSalesCertificates•TheGermanAuthoritystructureTopics1.Februar2020我们将讨论以下要点:•什么是欧盟代表•欧盟的产品注册•自由销售证明•德国主管部门的架构讨论要点1.Februar2020BeforeamedicaldevicecanbeplacedontheEuropeanmarket,themanufacturermust1.ConfirmthecompliancewiththerelevantEuropeandirectivesandaffixtheCE-markAnotifiedbodymaybeinvolvedinthisproceduretoprovidetheCE-certification2.Registerwiththecompetentauthority,inmostcountriesviaanelectronicdatabase(GermanyDIMDI)3.ManufacturerlocatedoutsidetheEuropeanUnionneedanEC-Repascontactpointforauthorities:EuropeanRegulations1.Februar2020在医疗器械在欧盟销售之前，制造商必须1.确认符合相关的欧盟指令并加贴CE标志可能需要认证机构参与此過程，以提供CE证书2.在主管当局的注册产品，大多数国家是通过电子数据库进行注册的（例如德国的DIMDI数据库）3.制造商若位于欧盟以外，则需要一個欧盟授权代表与主管当局接洽:欧洲法规1.Februar2020EuropeanAuthorizedRepresentative:meansanynaturalorlegalpersonestablishedintheCommunitywho,explicitlydesignatedbythemanufacturer,actsandmaybeaddressedbyauthoritiesandbodiesintheCommunityinsteadofthemanufacturerwithregardtothelatter'sobligationsunderthisDirective(93/42/EEC)1.Februar2020欧盟授权代表:指欧盟中的任何自然人或法人，其由生产商明确指定，按照(93/42/EEC)指令要求履行欧盟代表义务，并代表制造商接受欧盟主管部门和相关机构的接洽。1.Februar2020WhenisanEC-Representativeneeded?EverytimeyouwanttomarkoneofthefollowingproductswithaCE-mark,youneedanEC-Representative:•MedicalDevices•In-vitroDiagnosticDevices•ActiveImplantableMedicalDevices•WhenyousponsoraclinicalstudyinEuropeEC-Rep1.Februar2020什么时候需要欧盟代表（EC-Representative）?只要你想给任何以下产品打上CE标志，你就需要指定一个欧盟代表:•医疗器械•体外诊断器械•外源植入性医疗器械•当你在欧洲发起一个临床研究的时候EC-Rep1.Februar2020Duties:•Registrationofthedevice•Contactpointforauthorities•Incidentreportinginclosecooperationwiththemanufacturer•ReportingofFieldSafetyCorrectiveActions(FSCA)•ReportingofRecalls•KeepthelatestrevisionofthetechnicalfileoratleastextractstoprovidetoauthoritiesEC-RepmustbeincludedinthelabelorIFUofthedevice1.Februar2020职责:•产品注册•接受主管部门的联络问询•与制造商密切合作，完成事故报告•现场安全纠正措施(FSCA)报告•召回报告•保留最新版的技术文件，至少是摘要，以提供給主管部門审查欧盟授权代表必須出现在器械的标签或者使用说明上1.Februar2020Whenisaregistrationofadeviceneeded?Wheneveryouwantto„bring“aMedicalDevice/In-vitroDiagnosticDeviceintotheEuropeanCommunity„Bring“means:Registration•sell•promote•demonstrate•display•etc.1.Februar2020产品什么时候需要注册?一旦您要把某个医疗器械/体外诊断器械„引入“欧盟引入的意思是:产品注册•销售•推广•示范•展示•等等.1.Februar2020RegistrationprocedureEC-RepregisterstheproductswiththeauthoritiesofthecountryofhisplaceofbusinessFortheregistrationtheEC-Repmustsupplythefollowingdocuments:•CE-Certificate(ifapplicable)•DeclarationofConformityRegistration1.Februar2020产品注册流程欧盟代表要向他所在国家的主管当局注册产品欧盟代表要提供一下文件来注册:•CE证书(如有)•符合性声明（DeclarationofConformity）产品注册1.Februar2020RegistrationThecompetentauthoritymayrequestadditionalinformationsuchas:•productinformation/brochureorproductdescription•listofappliedstandardswithwhichcomplianceisclaimed•clinicalevaluationreport•summaryofbenchtesting/preclinicalevaluation•productlabelsandinstructionforuse1.Februar2020产品注册主管当局可能会额外要求以下文件:•产品信息/宣传页，或产品描述文件•一个列表，列出厂家声明产品符合的所有技术标准名称•临床评估报告•台架试验或临床前评估的综述•产品标签和使用说明书1.Februar2020RegistrationUponapprovaloftheregistrationanotificationoftheGermanElectronicDatabaseDIMDIwillbeprovidedBUTno„Certificate“1.Februar2020产品注册一旦注册通过审核，德国电子数据库DIMDI就会生成一个备案但没有„证书“1.Februar2020RegistrationBringingtheproductstoEuropecanbeginuponapplyingoftheregistration–Thereisnolegalneedtowaitforthefinalapproval1.Februar2020产品注册只要注册提交，产品就可以进入欧盟市场–不需要等注册通过后再进入欧盟1.Februar2020RegistrationCertaincountriesrequireadditionalregistrations:CroatiaFranceItalyLatviaLithuaniaPortugalSlovakiaSpain1.Februar2020产品注册一些国家要求额外的注册:克罗地亚法国希腊意大利拉脱维亚立陶宛葡萄牙斯洛伐克西班牙1.Februar2020RegistrationBelgiumandPolandrequirearegistrationbythelocaldistributor(importer)1.Februar2020产品注册比利时和波兰要求当地的经销商注册(进口商)1.Februar2020RegistrationAdditionalregistrationsMAYCOSTMONEYANDWILLREQUIREINMANYCASESLABELSANDINSTRUCTIONSFORUSEINLOCALLANGUAGES1.Februar2020产品注册额外的注册可能有相应的收费而且很多情况下要提交当地语言的产品标签和使用说明书1.Februar2020FreeSalesCertificatesFREESALESCERTIFICATESareneededtoenablesalesincertaincountriese.g.:•Egypt•Argentina•India•Brasil•Iran•etc1.Februar2020自由销售证明自由销售证明（FREESALESC