MedicalDevice
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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!
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!