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MDCG Publishes Application of MDR Requirements to Legacy Devices and Old Devices
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MDCG Publishes Application of MDR Requirements to Legacy Devices and Old Devices

MDCG Publishes Application of MDR Requirements to Legacy Devices and Old Devices

The Medical Device Coordination Group (MDCG) issued MDCG 2021-25 “Regulation (EU) 2017/745 — application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC” on October21,  2021. The task-force investigated in the document three following topics:

  • Application of requirements on postmarket and market surveillance, and vigilance according to Chapter VII of Regulation (EU) 2017/745 on medical devices (MDR) to ‘legacy devices’  
  • Application of other MDR requirements to ‘legacy devices’  
  • Application of MDR requirements to ‘old’ devices


Additionally, the task-force sent the report with its position on application of MDR requirements to ‘legacy devices’ and ‘old’ devices to the MDCG. 

It is also illustrated in the document which provisions of MDR are applicable to legacy devices and which are not. Here we show only the articles of the MDR that are applicable to legacy devices:


The full text of MDCG 2021-25 you can find here.


The information has been prepared by the GMA Consult Group team.

GMA Consult Group provides a full cycle of international type approval and global market access services for IT, Telecom, and industrial electrical products in all countries throughout the world. With proven expertise in worldwide regulations, compliance, certification, and conformity assessment, GMA Consult Group can help your company speed up the access to any market with almost zero efforts from your side.

Need your own guide to the world of certification and approvals? Don't hesitate to contact us via info@gma.trade.


December 2, 2021

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