Hello all! I have some questions on labeling a commercially available device that is being used as an investigational device in a protocol. The device manufacturer does not use expiry but only has a two year warranty listed. Has anyone ever experienced this or have any suggestions on how to approach the clinical labeling of expiry for outside of US (EU/MENA/LATAM/APAC). How to determine what expiry to place on the label or is there a way to bypass and still get QP release?

Any suggestions would be appreciated.
Thank you.