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Overview of medical device management and regulations in various ries
2023.03.15 Council Regulation (EU)2017/745 MDR Amendment 2023/607 and FAQ on extension of CE certificate for MDD
The European Parliament has approved a further extension of the MDR transition period

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Manufacturer training service

Here you will find literature on medical device topics, medical device approval, and MDR details, video courses, and some free downloads.Didn't find what you were looking for, or do you need more extensive advice? We'll be happy to answer your questions personally.

MDR
  MDR  EU 2017&745 英语版 (下 载)
  中文版MDREU2017745欧盟医疗器械法规20170505  中文翻译仅做参考 (下 载)
IVDR
  IVDR 2017 746 EN (下 载)
  IVDR （中文） CELEX_02017R0746-20170505_CN 中文翻译仅做参考 (下 载)
  IVDR过渡期概览 (下 载)