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IIb 类医疗器械的CE认证途径

IIb 类医疗器械的CE认证步骤

  1. 分类:确认产品属于IIb类医疗器械
  2. 选择符合性评估途径:请参考下面的流程图
  3. 编制技术文件
  4. 委任欧盟授权代表
  5. 从第三方公告机构(NB)获得CE证书
  6. (完成)CE符合性声明
  7. 将技术文件存放在欧盟授权代表处(供欧盟主管机关随时检查)
  8. 建立(售后)警戒系统/加贴CE标签并将产品投放EEA市场

Flow Chart of Class IIb MDD

Flow Chart of Class IIb MDD

Medical Devices MDD conformity assessment procedures table

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About CE Marking: