Contact Us
Introduction Services Fees Medical Devices Other Products Questions & Answers About Us Order Now!
What Is Why Need Why Not Distributor Registration in Europe Questions & Answers Why Wellkang
european authorized representative

手机: +86 135 3815 8788 (中文服务)
英国电话: +44 790 120 0000 (中文/英文服务)

Are you ready for Brexit? Do you have a Brexit contingency plan?

You may need either an EU/EC European authorized representative based in EU-27 countries or a UK authorised representative based in UK, or may even need both EU & UK representatives, depending on different brexit scenarios.

Register/Notify your MD-Medical Devices & IVD-In Vitro Diagnostic Medical
Devices with MHRA in UK & other EEA (EU/EFTA) authorities by world-leading
consultancy- Wellkang team based in UK (England), EU-27 (Ireland) & China.

Wellkang team can help you under all Brexit scenarios!
Click here to get FREE Guide Now!


IIa 类医疗器械的CE认证途径

IIa 类医疗器械的CE认证步骤

  1. 分类:确认产品属于IIa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 IIa MDD


Flow Chart of Class IIa MDD




Medical Devices MDD conformity assessment procedures table







Go to Top

About CE Marking:
如果您需要更多关于CE认证的信息,欢迎访问我们的常见问题解答部分.