Importer Address in addition to Manufacturer details on label

Ioko

Starting to get Involved
#1
Hi,

According to the MDR and the Blue guide, the importer of a MD in Europe must indicate his name, registered trade name or registered trade mark and the address at which he can be contacted on the product.

If the importer is part of the foreign manufacturer company (as a subsidiary), could the manufacturer apply on the product the information related to the importer before to send it to the importer?

Thank you for your help,
Ioko
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
could the manufacturer apply on the product the information related to the importer before to send it to the importer?
Do you mean apply the importer's info in addition to the manufacturer's info, or instead of the manufacturer's info?
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Hi Ronen,
I mean apply the importer’s info in addition to the manufacturer’s info.
Thank you
I don't see a problem, as long as the respective roles (manufacturer and importer) are unambiguous in the labelling.
What's the source of your concern?
 

Ioko

Starting to get Involved
#5
I don't see a problem, as long as the respective roles (manufacturer and importer) are unambiguous in the labelling.
What's the source of your concern?
In the blue guide or in the MDR, applying the importer's information is part of the Importer's obligation so I am just wondering if the manufacturer could do it instead of the importer.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
In the blue guide or in the MDR, applying the importer's information is part of the Importer's obligation so I am just wondering if the manufacturer could do it instead of the importer.
As far as I understand there is nothing preventing a party from taking on another party's obligations where they agree about that.
 

dgrainger

Trusted Information Resource
#8
It is clearly the duty of the importer to do this:

Importers shall indicate on the device or on its packaging or in a document accompanying the device their name,
registered trade name or registered trade mark, their registered place of business and the address at which they can be
contacted, so that their location can be established. They shall ensure that any additional label does not obscure any
information on the label provided by the manufacturer.
 

Ronen E

Problem Solver
Staff member
Moderator
#9
It is clearly the duty of the importer to do this:

Importers shall indicate on the device or on its packaging or in a document accompanying the device their name,
registered trade name or registered trade mark, their registered place of business and the address at which they can be
contacted, so that their location can be established. They shall ensure that any additional label does not obscure any
information on the label provided by the manufacturer.
Of course, it's their responsibility (i.e. they will be held accountable in case of non-compliance), but that doesn't forbid or prevent another entity of doing it for them.

Anyway, it's a rather moot point in this case since the importer is part (a subsidiary) of the manufacturer.
 

dgrainger

Trusted Information Resource
#10
It's different to the other clauses that state that "Importers shall ensure that...", this one appears to have to be done by the Importer (well, that's how "shall" is interpreted in the UK!)
 
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