EU Representative Contact Address question

A

Achemd

#1
Do we need to put a persons name on the packaging and insert or will the companies name be sufficient with the contact address? I hate to make a revision everytime the person changes.

Thank you
 
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GStough

Staff member
Super Moderator
#2
Re: EU Representative Question

Do we need to put a persons name on the packaging and insert or will the companies name be sufficient with the contact address? I hate to make a revision everytime the person changes.

Thank you
The company's name/address should be sufficient for contact information. I would not recommend using a person's name for the very reason you stated. :tg:

You may identify the person's title in the org chart or other QMS documentation, however.
 
Last edited:
Y

YairP

#3
Re: EU Representative Question

The company's name/address should be sufficient for contact information. I would not recommend using a person's name for the very reason you stated. :tg:

You may identify the person's title in the org chart or other QMS documentation, however.
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.
 

GStough

Staff member
Super Moderator
#4
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.
Well, I suppose it may also depend on the type of device and its intended use. The device we produce cannot have a label attached to it, so the label is on the package.
 

burovoy

Starting to get Involved
#5
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.

:2cents:
 
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