Artworks and labels form part of your medical device technical file. If an artwork and/or label is changed the corresponding section in the technical file needs to be updated.
IFU(s) and label texts are part of the product which come into direct contact with the consumers. It must be stressed non-compliant artworks and labels can be the cause of serious compliance issues, which in the worst case can lead to batch and/or product recalls. Batch and/or product recalls could cost a company millions.