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Instructions for Use (IFU) - On the Manufacturer's Website vs. On the Product Label

J

jewels

#11
#11
IFU in other formats than paper

We implemented a system of putting our IFUs, and other paperwork on a CD that is included with the product. This has been a great cost savings.

Canada requires a paper copy be in with the product. So, we put an English paper copy of all paperwork in the product and everything else goes on CD.

Just another option that might help.
 
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A

Al Rosen

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#12
#12
jewels said:
We implemented a system of putting our IFUs, and other paperwork on a CD that is included with the product. This has been a great cost savings.

Canada requires a paper copy be in with the product. So, we put an English paper copy of all paperwork in the product and everything else goes on CD.

Just another option that might help.
Click to expand...
Thanks for the information.
 
R

rose24m03

#13
#13
For Canada, they take French or English. Note: The manufacturer shall make directions for use in the other official language available as soon as possible at the request of the purchaser. IFU on a CD ROM is acceptable as long as you are able to provide paper copies on request.
 
M

mr.mike

#14
#14
Re: Instructions for Use (IFU) - On the manufacturer's website vs. On the product lab

Canada requires a paper copy be in with the product.
Click to expand...
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?
 
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