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MDR Requirements - UDI/Barcodes/QR codes on IFUs

MedicalDevice

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#1
Hi all,

As we all know, the new MDR has the mandatory implementation of the new UDI system in all levels of packaging.
My question is:
Do we also need to include the UDI on the IFU of the product? To my understanding, this is something very expensive to implement, since organizations will be required to print a different IFU for each different batch of every product.
If it is a compulsory requirement, is there any way to avoid including the barcode on the IFU? (through eIFU or any other way...?)
Thank you in advance for your help!
 
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MedicalDevice

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#3
Thank you Ronen!
I was under the impression that the UDI (or old barcode) and the "REF" (catalog number) needed to appear on the IFU too.
 

twanmul

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#5
They aren't mandated from what I can see, though is this not an easy way to put a link to the Summary of Safety & Clinical Performance for devices which require it? I thought that the UDI should link to the Summary of Safety & Performance, though maybe I'm wrong?
 
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