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Electronic IFU - new project, need input

QIE

Registered
#1
I have just been given a project to investigate/implement electronic IFU. Does the FDA accept eIFU for med devices? I see that the EU Commission Regulation No 207/2012 lists 5 types of medical devices it applies to, but does that mean that other categories of med devs CANNOT use eIFU or does it mean that they don't have to comply with all the requirements in the regulation? What about other countries? Any guidance would be appreciated.
 
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