Electronic IFU's on Class III and IV Medical Devices World Wide

D

deuce64

#1
I recently saw that the EU community is recognizing a new guidance that allows e-ifu's on class III and IV medical devices. This paves the way for some cost savings on EU/USA distributed devices. Wondering how others are viewing this and also if they are developing strategies for their rest-of-world registrations. For instance - i have a high volume (multi-sku) product line that could save multi thousands in cost to produce. However, this mainly benefits USA and EU. If we get an order from say, Ecuador, for the same product, how to handle the addition of the IFU? Or is there a harmonized standard? that is allowing this in the terciary geographies? I'd hate to create a whole other line of SKU numbers to deal with this.
thanks for any help.
 
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Marc

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#2
A quick "Bump". My Thanks in advance to anyone who can help with this one.
 
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