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Mandatory information in Conformity Declaration for Medical Device Class I
Hello, I have a Conformity Declaration from a supplier for MD Class I non-sterile, under MDR 2017/745, that identifies the product with "name", "model" (uses the references of the products), "GMDN" and "Classification" (Class I). There is already a text field for "Basic UDI-DI", but is still empty. Recently I asked for a new product class I with a new reference, produced only for us. I asked for an update of the Conformity Declaration and the supplier told me the one I have is enough for the new reference because it is under the same "Name" and "GMDN". Is that correct? Doesn't the MDR oblige to an "unambiguous reference allowing identification and traceability of the device", for this one in particular? Shouldn't the supplier add the new "Model"? Additionally, when will the Basic UDI-DI be mandatory in these declarations? Thank you, Isabel Sottomayor