CE认证-欧盟授权代表及其法规介绍

1、10.07.2020,Who is MedNet,GmbH is a German Sales and Marketing Organization offering European Authorized Representation Service worldwide Offer EAR serivce: since 1993 Headquarter: Mnster Germany Offices: UK, Israel, China Active in. European Countries We are one of the Largest and First Class provid

2、er of the service in Europe,10.07.2020,MedNet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一,10.07.2020,Professional EAR service for Medical Devices fast and professional Registration supply Free Sales Certifcate Legalize the

3、 documents as you need 1000 product registrations performed for 3000 products MedNet is ISO 13485 certified MedNet understands medical devices We are fast and cost effective,MedNet Advantages,10.07.2020,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（Free Sales Certifcate） 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

4、产品注册 MedNet 拥有 ISO 13485 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,10.07.2020,In this presentation we discuss, what happens after having received the CE-mark 在这里，我们将讨论： 拿 到 CE 标 志 后，会 发 生 什 么,Topics,10.07.2020,We will cover the following topics: What is an EC-Representative Product regist

5、ration issues in Europe Free Sales Certificates The German Authority structure,Topics,10.07.2020,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,10.07.2020,Before a medical device can be placed on the European market, the manufacturer must Confirm the compliance with the relevant E

6、uropean directives and affix the CE-mark A notified body may be involved in this procedure to provide the CE-certification Register with the competent authority, in most countries via an electronic database (Germany DIMDI) Manufacturer located outside the European Union need an EC-Rep as contact poi

7、nt for authorities:,European Regulations,10.07.2020,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,10.07.2020,European Authorized Representative: means any natural or legal person established in the Commu

8、nity 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),10.07.2020,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

9、盟主管部门和相关机构的接洽。,10.07.2020,When 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 Europe,EC-Rep,1

10、0.07.2020,什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-Rep,10.07.2020,Duties: Registration of the device Contact point for authorities Incident reporting in close cooperation with the manufacturer Reporting of Field Safety Corrective Actio

11、ns (FSCA) Reporting of Recalls Keep the latest revision of the technical file or at least extracts to provide to authorities EC-Rep must be included in the label or IFU of the device,10.07.2020,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

12、或者使用说明上,10.07.2020,When is a registration of a device needed ? Whenever you want to bring“ a Medical Device / In-vitro Diagnostic Device into the European Community Bring“ means:,Registration,sell promote demonstrate display etc.,10.07.2020,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

13、注册,销售 推广 示范 展示 等等.,10.07.2020,Registration procedure EC-Rep registers the products with the authorities of the country of his place of business For the registration the EC-Rep must supply the following documents: CE-Certificate (if applicable) Declaration of Conformity,Registration,10.07.2020,产 品 注

14、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 （Declaration of Conformity）,产品注册,10.07.2020,Registration,The competent authority may request additional information such as: product information/brochure or product description list of applied standards with which compliance is claimed clin

15、ical evaluation report summary of bench testing/preclinical evaluation product labels and instruction for use,10.07.2020,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,10.07.2020,Registration,Upon approval of the registration a notification of the Ge

16、rman Electronic Database DIMDI will be provided BUT no Certificate“,10.07.2020,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“,10.07.2020,Registration,Bringing the products to Europe can begin upon applying of the registration There is no legal need to wait for the final approval,10.07.2020,产品注册,只要注册提交，产

17、品就可以进入欧盟市场 不需要等注册通过后再进入欧盟,10.07.2020,Registration,Certain countries require additional registrations: Croatia France Italy Latvia Lithuania Portugal Slovakia Spain,10.07.2020,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,10.07.2020,Registration,Belgium and Poland require a registration by t

18、he local distributor (importer),10.07.2020,产品注册,比利时 和 波兰 要求当地的经销商注册 (进口商),10.07.2020,Registration,Additional registrations MAY COST MONEY AND WILL REQUIRE IN MANY CASES LABELS AND INSTRUCTIONS FOR USE IN LOCAL LANGUAGES,10.07.2020,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,10.07.2020,Free Sales C

19、ertificates,FREE SALES CERTIFICATES are needed to enable sales in certain countries e.g.: Egypt Argentina India Brasil Iran etc,10.07.2020,自由销售证明,自 由 销 售 证 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.,10.07.2020,Free Sales Certificates,FREE SALES CERTIFICATES Can only be o

20、btained by the EC-Representative for registered products,10.07.2020,自由销售证明,自 由 销 售 证 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,10.07.2020,Free Sales Certificates,Free Sales Certificates in Germany Timeline: 3 4 weeks not including necessary legalisation time,10.07.2020,自由销售证明,德国的自由销

21、售证明 时间: 3 4 周 不 包 括 额 外 认 证 的 时 间,10.07.2020,The Federal Institute for Drugs and Medical Devices (BfArM) is an independent higher federal authority within the portfolio of the Federal Ministry of Health Central collection, analysis and evaluation of risks and coordination of measures Cooperation wit

22、h 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 all matters concerning risk prevention. Consultancy Service regarding classification and safety aspects of medical devices,10.07.2020,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、分析和评估风险，并协调各项措施 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、