Good morning,
here comes an awkward question
I am a medical devices CER writer and I am looking some (official, wishfully) guidelines on the extent of plagiarism we we "allowed" to practice when writing the State of the Art Section and when appraising clinical data on equivalent devices.
Does anyone have any examples where a Notified Body rejected a CER because plagiarism was detected in these two sections?
Do you think we should treat the CER as an original paper that will undergo peer-review, therefore all plagiarism rules apply, or we could be a bit more flexible given that this is a regulatory document that remains confidential throughout the process?
Any thoughts will be highly appreciated!