体外诊断试剂欧盟CE认证详解-IVDD 98/79/EC要求

体外诊断试剂欧盟法规

体外诊断试剂出口欧盟需按照体外诊断器械指令IVDD 98/79/EC要求进行认证

98/79/EC Scope法规范围：

This Directive shall apply to in vitro diagnostic medicaldevices and their accessories. For the purposes of this Directive,accessories shall be treated as in vitro diagnostic medical devicesin their own right. Both in vitro diagnostic medical devices andaccessories shall hereinafter be termed devices.

体外诊断试剂CE认证要求

1 工厂要满足ISO 13485医疗体系的要求

2 准备CE技术文件：产品介绍，使用说明书、风险分析报告、包装标签样本等

3 按照IVDD 98/79/EC 附录III的要求签发EC合格声明

EC DECLARATION OF CONFORMITY下载

4 制造商需去成员国的主管当局competent authorities注册，若制造商非欧盟公司，需委托欧盟代表帮助制造商完成注册

98/79/EC Article 10 Registration of manufacturers anddevices

1. Any manufacturer who places devices on the market under hisown name shall notify the competent authorities of the Member Statein which he has his registered place of business:

— of the address of the registered place of business,

— of information relating to the reagents, reagent products andcalibration and control materials in terms of common technologicalcharacteristics and/or analytes and of any significant changethereto including discontinuation of placing on the market; forother devices, the appropriate indications,

— in the case of devices covered by Annex II and of devices forself-testing, of all data allowing for identification of suchdevices, the analytical and, where appropriate, diagnosticparameters as referred to in Annex I, part A, section 3, theoutcome of performance evaluation pursuant to Annex VIII,certificates and any significant change thereto, includingdiscontinuation of placing on the market.

关于‘’欧代‘’请见：医疗器械、医疗体外诊断试剂等欧盟代表ECRepresentative如何申请？

5 按照98/79/EC Article 16要求加贴CE标识

98/79/EC Article 16 CE marking

Devices, other than devices for performance evaluation,considered to meet the essential re referred to inArticle 3 must bear the CE marking of conformity when they areplaced on the market.

拥有英国BSI、德国TUV、土耳其UDEM等**公告机构授权，可提供专业高效的医疗器械和医疗器械体外诊断试剂的CE认证服务。