Canada requires a paper copy be in with the product.
It is unfortunate that Canada requires a paper copy of the IFU.
Is this explicitly stated in the SOR/98-282 Canadian Medical Device Regulations?
I can't seem to see any mention of electronic IFUs anywhere in there, so are we to assume that electronic IFUs are not acceptable? Anyone know what Canada's stance is on electronic instructions?
It seems that most of the rationale behind having printed copies is the potential that the end-user does not have access to electronic medium (CD-ROM reader, internet access...etc.).
In our case, our device comes with a computer (you cannot use it without). We provide PDF copies of all the IFUs on the desktop.
From a risk standpoint, there is no way a person can operate the device and not be able to access these electronic IFUs. Can this be an argument for the exclusion of printed copies? ...or is there no leeway here?