J
jennaleeb
Hi there! We are a small manufacturer of Class I sterile medical devices. We want to offer our customers customized packaging (different sized boxes, labelling languages, different pictures for the IFU, etc) depending on their needs.
What does this mean from a regulatory perspective? If the device is CE marked do we have to notify the CA/NB every time there is a new packaging configuration if it does not affect risk/product quality/etc?
THANKS to everyone who posts on this forum!
What does this mean from a regulatory perspective? If the device is CE marked do we have to notify the CA/NB every time there is a new packaging configuration if it does not affect risk/product quality/etc?
THANKS to everyone who posts on this forum!