ce认证-欧盟授权代表及其法规介绍.pptxVIP

Who is MedNet GmbH is a German Sales and Marketing Organization offering European Authorized Representation Service worldwide Offer EAR serivce: since 1993 Headquarter: Münster – Germany Offices: UK, Israel, China Active in... European Countries We are one of the Largest and First Class provider of the service in Europe March 30, 2018 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 March 30, 2018 March 30, 2018 Professional EAR service for Medical Devices fast and professional Registration supply Free Sales Certifcate Legalize the 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 March 30, 2018 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 March 30, 2018 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 March 30, 2018 We will cover the following topics: What is an EC-Representative Product registration issues in Europe Free Sales Certificates The German Authority structure Topics March 30, 2018 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 March 30, 2018 Before a medical device can be placed on the European market, the manufacturer must Confirm the compliance with the relevant European 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 point for autho