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:
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• 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.

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

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