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european union, european union regulations and standards, fda (food and drug administration), instructions for use (ifu), labeling requirements, labels and labeling (general), medical devices (general)
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  #9  
Old 15th February 2006, 09:21 AM
quest quest is offline
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Thanks

Thank you for the info. Article was helpful. So it sounds like it will depend on the country. As we mainly sell in the UK, E-labeling sounds like quite a cost saver for us.

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Old 16th February 2006, 01:58 PM
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Hardcopy IFU

It depends on the countries. For examples, these countries require hardcopy IFU: Croatia, Czech Republic, Japan, Netherlands, China, Romania, and Taiwan.

Note: Many countries require some if not all of the following be in their national language(s), not just IFU: User Interface/Software, Keyboard, Warning Labels, Service Documents, Brochures, etc.
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Old 26th April 2006, 05:47 PM
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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.
Thanks to jewels for your informative Post and/or Attachment!
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Old 26th April 2006, 05:58 PM
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Quote:
In Reply to Parent Post by jewels

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.
Thanks for the information.

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Old 8th June 2006, 08:35 PM
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Re: Instructions for Use (IFU) - On the manufacturer's website vs. On the product label

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.
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Old 25th May 2012, 12:39 PM
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Re: Instructions for Use (IFU) - On the manufacturer's website vs. On the product lab

Quote:
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?
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Old 27th May 2012, 04:58 AM
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Re: Instructions for Use (IFU) - On the Manufacturer's Website vs. On the Product Lab

COMMISSION REGULATION (EU) No 207/2012
of 9 March 2012
on electronic instructions for use of medical devices

http://eur-lex.europa.eu/LexUriServ/...28:0031:EN:PDF

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Old 27th May 2012, 11:42 PM
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Re: Instructions for Use (IFU) - On the Manufacturer's Website vs. On the Product Lab

Please see the notice from HCSC from Nov 9, 2010.

http://www.hc-sc.gc.ca/dhp-mps/md-im...onique-eng.php
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