欧盟医疗器械CE认证流程介绍

CE不是质量标志，但符合欧盟医疗器械法规（MDR 2017/745）要求您满足产品类型的性能，质量，安全性和功效的特定标准。具体操作步骤如下：

● 根据 MDR 确定您的产品是否符合医疗器械的定义。

● 确定设备的分类

● 实施质量管理体系（如果适用于您的设备）。大多数公司使用ISO 13485来满足要求。

● 准备CE标志技术文件或设计档案。

● 根据 MEDDEV 2.7/1 rev4 和 MDR 编写临床评估报告 （CER）。

● 如果您在欧洲没有实际位置，请选择并任命一名欧洲授权代表（EC REP）在欧盟境内代表您行事。

● 让您的质量管理体系和技术文件/设计档案由公告机构审核，除非您的设备是I类，不是无菌的，并且没有测量功能。

● 从您的公告机构获得CE标志和ISO 13485证书。

● 准备符合性声明 （DoC），声明您的设备符合 MDR。

How to obtain CE certification for medical devices

CE is not a quality mark, but it complies with the European Medical Device Regulation (MDR 2017/745), which requires you to meet the specific standards for the performance, quality, safety and efficacy of the product type. The specific operation steps are as follows:

● Determine whether your product meets the definition of medical device according to MDR.

● Determine the classification of equipment

● Implement a quality management system (if applicable to your equipment). Most companies use ISO 13485 to meet the requirements.

● Prepare CE mark technical documents or design archives.

● Prepare clinical evaluation report (CER) according to MEDDEV 2.7/1 rev4 and MDR.

● If you do not have a physical location in Europe, please select and appoint a European Authorized Representative (EC REP) to act on your behalf in the EU.

● Let your quality management system and technical documents/design archives be reviewed by the notified body, unless your equipment is Class I, not sterile, and has no measurement function.

● Obtain the CE mark and ISO 13485 certificate from your notified body.

● Prepare a Declaration of Conformity (DoC) stating that your equipment complies with the MDR.