Is anyone else having issues exporting medical devices to Germany? For many years, our CE marked product has been "over-labeled" by our German distributor so that the Instructions For Use are in German when sold to the hospital. We've now had two shipments held up. Our distributor talked with someone at the Ministry of Health and she told him that as soon as he relabels the boxes, he becomes the manufacturer. He would then need his own CE mark, would take on the liability, and would need to submit all documentation to the Ministry relating to manufacturing processes, sterilization, etc.
She also said that the Authorized Rep in the EU is considered the manufacturer, since their name and address is on each box.
The only option she suggested, which won't help with the shipment currently being held, is for us to over-label with IFU in German PRIOR to shipping.
So my question is not whether or not translations are required--I know they are--but when they need to be applied. The auditors in our recent MDSAP/ISO audit looked at translated materials, but seemed fine with those being used just by the distributor. I realize there are country-specific rules, and is that the case for Germany? And is it true that anyone who adds a label becomes the manufacturer?
She also said that the Authorized Rep in the EU is considered the manufacturer, since their name and address is on each box.
The only option she suggested, which won't help with the shipment currently being held, is for us to over-label with IFU in German PRIOR to shipping.
So my question is not whether or not translations are required--I know they are--but when they need to be applied. The auditors in our recent MDSAP/ISO audit looked at translated materials, but seemed fine with those being used just by the distributor. I realize there are country-specific rules, and is that the case for Germany? And is it true that anyone who adds a label becomes the manufacturer?