Good day Malin,
There is no specific requirement for retention of samples for medical devices; you will often find this type of information more related to pharmaceutical products (GMP). This is left up to each medical device manufacturer based on type of device, though there are some guidance documents from different regulators which talk around this. Manufacturers can determine this need: depending on the medical device a retain sample per lot/batch would be made for future complaint investigation or future evaluation such as needed for design activities or manufacturing review. Working for a few companies we would take a small statistical sample of units from a lot/batch of product which would be maintained based on the shelf life or expiration date. This does take physical space as well and needs to be managed. I worked for an IVD company where we maintained retain samples for planned shelf life extension activities (real time aging), complaint investigation, and also evaluation of samples at defined periods of time within the expiration date for our own data analysis. The closest regulatory requirement probably you would find is ISO 13485 Section 7.1(d) where (planning) evidence of realization of processes and results are maintained. Of course there is quite an interpretation and stretch applied to retention samples, but unfortunately I have seen audit observations for not retaining samples before. Also note under EU MDR, as an example, Notified Bodies may request samples of product so it would be helpful to have some samples available (US FDA can do this as well).
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 15-Nov-2021 10:51
From: Malin Kylberg
Subject: Retention samples for medical devices
Does anybody knows if there are official FDA requirements for retain samples for Medical Devices like for the pharmaceutical industry?
Thanks in advance!
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Malin Kylberg
Director QA & RA
Skutskär
Sweden
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