Annual product review / Retention samples for medical devices.

Dear Members, I really appreaciate your comments on the following question: are the requirements from the Pharma industry to perform annual product review and managing retention samples also somehow applicable for IVD medical devices? Thank you.

1 Replies
There is no requirement for annual product review per se, and no retention sample requirement unless it's part of establishing expiration date.
The QSR uses CAPA related activities instead of annual product review.
See attached file with items from the QSR preamble and regulation.

File Attachments