UDI - OEM or OBL / Legal Manufacturer Responsibility

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victorsyj

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#1
#1
I would like to know more about the UDI requirements under EU MDR. We are Original Equipment Manufacturer (OEM), we produce medical devices and assign the labels that our customer (OBL / Legal Manufacturer) want. 1 of our customers who market their devices in EU requested us to subscribe to GS1 and assign the devices with GS1 labels. Our question is, these medical devices belong to them, are we the one to subscribe to GS1 and assign the labels? Or our customer should be the one to subscribe to GS1 and send us the labels for us to assign onto their products?
 
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