Retention Samples for medical devices

#1
Hello all,

I am wondering if there is any regulation for retention samples of medical devices. I was looking through the MDR, MPG, MPDG (both german national law, MPDG replaced the MPG since the MDR came into force), ISO:13485, and I could not find any paragraph or hint for how to handle retention samples for medical devices. I know that the gmp has got exact requirements for pharmaceutical products and I am searching for anything that is usable for medical devices in particular.

Is it all just a question how the company set the requirements within the process?

Thanks for all replys in advance, maybe you can help me out :)

Greetings from Berlin,
Paul
 
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shimonv

Trusted Information Resource
#2
Unlike pharmaceutical, there is no requirement for sample retention in medical devices. In fact, in most cases there is no logic in doing so. It is done only in certain products where the statbilty of some of the components cannot be fully verified. Retention period is typically according to the expected shelf life / service life of the device.
 

planB

Super Moderator
#3
Paul,

adding to what shimonv said: in case you performed quality-relevant tests under GLP, test samples might be stored in order to meet GLP retention requirements.
 
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