EU MDR labels

Ololo

Registered
#1
Hi, I am looking to understand what flexibility exist for meeting the EU MDR requirements to provide importer details. Currently, there are no importer details on EU MDR label and IFU. We cannot complete EO Verification without it. Is it possible to put extra label with importer symbol or overelable MDR product. Thanks in advance.
 
Elsmar Forum Sponsor
#2
Hi,
I wouldn't place an extra label, even as this seems possible acc. to MDR saying, that if yo use an additional label, that you need to make sure, that there is nothing important overlabeled. You or rather the manufacturer also need to consider this as risk in your risk assessment and also you need to have a contract with fixing the responsibilities and that also includes the labelling. After all and under practical aspects, its much easier to simply mention the Importer on the label or why do you want to initiate that extra work with an extra label and/or overlabeling?
 
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