Electronic Instructions for use (eIFU)

#1
Hi all
I'm going to perform a risk analysis of our eIFU according to REGULATION (EU) No 207/2012.Has anyone performed this, and how did you do it? I'm struggling a bit.
 
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#2
Think of the 9 bullet points listed in Article 4 as questions to be asked and answered.

For instance, (d) access of the user to the ...electronic resources needed at the time of use.

You have to decide, depending upon how and where your device is used, how likely it is that the end user will have, say, a PC available to them at the time of need. Also, what happens if they do not have such access - perhaps your device is so simple to use that they would be unlikely to struggle; or, conversely, it may be so complex that even an experienced professional would require constant reference to the IfU.
 
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