CE认证-欧盟授权代表及其法规介绍

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1、6/30/2022MedNet是是谁谁 ? 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一6/30/2022Professional EAR service for Medical Devicesfast and professional Registrationsupply Free Sales CertifcateLegalize the documents as you need 1000 product

2、registrations performed for 3000 productsMedNet is ISO 13485 certifiedMedNet understands medical devices We are fast and cost effectiveMedNet Advantages6/30/2022为医疗器械提供专业的欧盟授权代表专业的欧盟授权代表服务快速专业的产品注册产品注册申请自由销售证明（自由销售证明（Free Sales Certifcate）帮您给需要的文件办理认证办理认证已经为超过已经为超过3000的产品，办理了约的产品，办理了约1000多个产品注册多个产品注

3、册MedNet 拥有 ISO 13485 认证MedNet 熟悉医疗器械和相关欧盟法规 我们我们 速度更快速度更快 而且而且 为您节省费用为您节省费用MedNet 的优势6/30/2022In this presentation we discuss, what happens after having received the CE-mark在这里，我们将讨论：在这里，我们将讨论： 拿拿 到到 CE 标标 志志 后，会后，会 发发 生生 什什 么么Topics6/30/2022We will cover the following topics: What is an EC-Represen

4、tative Product registration issues in Europe Free Sales Certificates The German Authority structureTopics6/30/2022我们将讨论以下要点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6/30/2022Before a medical device can be placed on the European market, the manufacturer mustConfirm the complianc

5、e with the relevant European directives and affix the CE-markA notified body may be involved in this procedure to provide the CE-certificationRegister with the competent authority, in most countries via an electronic database (Germany DIMDI)Manufacturer located outside the European Union need an EC-

6、Rep as contact point for authorities:European Regulations 6/30/2022在医疗器械在欧盟销售之前，制造商必须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）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6/30/2022European Authorized Representative:means any natural or legal person established in the

7、Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latters obligations under this Directive (93/42/EEC)6/30/2022欧盟授权欧盟授权代表代表: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

8、表制造商接受欧盟主管部门和相关机构的接洽。6/30/2022When is an EC-Representative needed ?Every time you want to mark one of the following products with a CE-mark, you need an EC-Representative: Medical Devices In-vitro Diagnostic Devices Active Implantable Medical Devices When you sponsor a clinical study in EuropeEC-Rep

9、6/30/2022什么时候需要欧盟代表（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-Rep6/30/2022Duties: Registration of the device Contact point for authorities Incident reporting in close cooperation with the manufacturer Reporting of Field Safety Corrective

10、Actions (FSCA) Reporting of Recalls Keep the latest revision of the technical file or at least extracts to provide to authoritiesEC-Rep must be included in the label or IFU of the device6/30/2022职责职责: 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 欧盟授权欧盟授权代表必須出

11、代表必須出现现在器械的在器械的标签标签或者或者使用使用说说明上明上6/30/2022When is a registration of a device needed ?Whenever you want to bring“ a Medical Device / In-vitro Diagnostic Device into the European CommunityBring“ means:Registration sellpromotedemonstratedisplayetc.6/30/2022产产 品品 什什 么么 时时 候候 需需 要要 注注 册册?一旦您要把某个医疗器械 / 体外

12、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.6/30/2022Registration procedureEC-Rep registers the products with the authorities of the country ofhis place of businessFor the registration the EC-Rep must supply the followingdocuments:CE-Certificate (if applicable)Declaration of ConformityRegistration 6/30/2022产

13、产 品品 注注 册册 流流 程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 （Declaration of Conformity）产品注册 6/30/2022Registration The competent authority may request additional information such as: product information/brochure or product description list of applied standards with which compliance is claimed

14、clinical evaluation report summary of bench testing/preclinical evaluation product labels and instruction for use 6/30/2022产品注册 主管当局可能会额外要求以下文件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 6/30/2022Registration Upon approval of the registration a notific

15、ation of the German Electronic Database DIMDI will be providedBUT no Certificate“ 6/30/2022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但没有 证书证书“ 6/30/2022Registration Bringing the products to Europe can begin upon applying of the registration There is no legal need to wait for the final approval 6/30/2022产

16、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 6/30/2022Registration Certain countries require additional registrations:Croatia FranceItalyLatvia LithuaniaPortugalSlovakiaSpain 6/30/2022产品注册 一些国家要求额外的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 6/30/2022Registration Belgium and Poland require a registration

17、 by the local distributor (importer) 6/30/2022产品注册 比利时比利时 和和 波兰波兰 要求当地的经销商注册 (进口商) 6/30/2022Registration Additional registrations MAY COST MONEY AND WILL REQUIRE IN MANY CASES LABELS AND INSTRUCTIONS FOR USE IN LOCAL LANGUAGES 6/30/2022产品注册 额外的注册额外的注册 可能有相应的收费可能有相应的收费 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而且很多情况

18、下要提交当地语言的产品标签和使用说明书 6/30/2022Free Sales Certificates FREE SALES CERTIFICATESare needed to enable sales in certain countries e.g.: Egypt Argentina India Brasil Iran etc 6/30/2022自由销售证明自自 由由 销销 售售 证证 明明（FREE SALES CERTIFICATES）一些国家需要产品提供这个证明才允许销售，比如：埃及阿根廷印度巴西伊朗等等. 6/30/2022Free Sales Certificates FREE

19、 SALES CERTIFICATESCan only be obtained by the EC-Representative for registered products 6/30/2022自由销售证明自自 由由 销销 售售 证证 明明FREE SALES CERTIFICATES获得该证明的前提： 由欧盟代表申请证明 产品已经完成并通过了注册注册 6/30/2022Free Sales Certificates Free Sales Certificates in GermanyTimeline: 3 4 weeksnot including necessary legalisatio

20、n time 6/30/2022自由销售证明德国的自由销售证明德国的自由销售证明时间: 3 4 周不不 包包 括括 额额 外外 认认 证证 的的 时时 间间 6/30/2022The Federal Institute for Drugs and Medical Devices (BfArM) is an independent higher federal authority within the portfolio of the Federal Ministry of HealthCentral collection, analysis and evaluation of risks an

21、d coordination of measures Cooperation with local federal authorities, competent authorities of other EU member states, the European commission, or other bodies Evaluation and approval of clinical studies/performance evaluations Cooperation with competent authorities of the other EU Member States in

22、 all matters concerning risk prevention. Consultancy Service regarding classification and safety aspects of medical devices6/30/2022联邦药品和医疗器械研究院（BfArM）是一個德国联邦卫生部的独立高级联邦机构 集中收集、分析和集中收集、分析和评估风险评估风险，并协调各项并协调各项措施措施 与其它欧盟成员国当地的联邦机构和主管当局、欧盟委员会及其它机构合作 评估并批准临床研究、性能评估 与其它欧盟成员国的主管当局在一切风险防范相关事宜上合作 提供医疗器械分类和安全方

23、面的咨询服务6/30/2022Market surveillance is not done by the BfArM but by the local authority in the district where the EC-Rep is located: Bezirksregierung MnsterHandling of registrations of medical devices in their district Inspection of manufacturers or authorized representatives of medical devices (On-S

24、ite)Random inspection of technical files to ensure conformity with the regulations Surveillance of corrective actions 6/30/2022市市 场场 监监 管管不是由BfArM负责，而是由欧盟授权代表所在当地的主管部门负责：Bezirksregierung明斯特明斯特办理其区域內的医疗器械注册检查医疗器械的制造商或欧盟授权代表（现场检查）随机检查技术文档，以确保符合相关法规监监管管纠正纠正措施措施6/30/2022MedNet GmbH, Borkstrae 10, 48163 Mnster, Germanywww.mednet- / Tel +49 251 32266 0 / Fax +49 251 32266 22中国联系: +86 132 1016 7238 Thank You!