25-year lifetime of medical device - document storage period

#1
Hello,

Maybe somebody can help me with that: how long should we retain documents and records (such as declaration of conformity, technical documentation, documentation of quality system, decisions and records from notified body, etc.) if our medical device have 25-year lifetime? Thank you in advance for your help. :)
 
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shimonv

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#2
This is taken from MDR, Article 10(8) - General obligations of manufacturers:
Screen Shot 2021-04-07 at 15.59.36.png

If your device has an expected lifetime of 25 years, that I'll keep it for that long.

Shimon
 
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