Re: EU Representative Question
My understanding is that the EU Representative label should be placed on the Device, not on the Device Package? On the device package we are placing company Name & Address.
Medical Device Directive, Annex I:
"..13.3 The label must bear the following particulars:
13.3(a)- the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of either the person responsible referred to in Article 14 (2) or of the
authorized representative of the manufacturer established within the Community or of the importer established within the Community, as appropriate...."
This means that the label/outer packaging/instructionfor use, depending on where the manufacturer/EU rep information is placed, must contain both the manufacturer's and the EU representative's name and address.
