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MDR Requirements - UDI/Barcodes/QR codes on IFUs


Starting to get Involved
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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Starting to get Involved
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.


Involved In Discussions
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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