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EU 207/2012 E-IFU Service Video

#1
If a service video is added to an electronic medical device and that service video contains the same information that is found within the provided paper IFU, is it considered a medical device fitted with a built-in system visually displaying the instructions for use and thus requiring compliance to 207/2012? Thank you!
 
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#2
As I see it, Article 9 of the regulation applies:
"Instructions for use in electronic form which are provided in addition to complete instructions for use in paper form shall be consistent with the content of the instructions for use in paper form. "

As long as it is not "instead of" but "in addition to" and it is not on a website, none of the rest applies. However, if you also make the video available on a website, then this part of Article 9 applies:
"Where such instructions for use are provided through a website, this website shall fulfil the requirements set out in points (b), (e) and (g) of paragraph 2 of Article 7. "
 
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