Authorized Representative on Labeling (MDR)

[thenewbiemdr]

Hi,

I have a question for information on the label.

I understand according to MDR,

the label shall bear below one of the details as listed below.

• if the manufacturer has its registered place of business outside the Union, the name of the authorized representative and address of the registered place of business of the authorized representative

So, can the label refer to carton label? Or the label on the product must have also the authorized representative information?

Appreciate if anyone can advice.

 

[shimonv]

Hi thenewbiemdr,

1. The MDR defines 'label' as:
‘label’ means the written, printed or graphic information appearing either on the device itself, or on the packaging of each unit or on the packaging of multiple devices;"

To your question - the EU rep info should appear on the device label or the immediate packaging.

2. The MDD which is the current regulation says the following in Annex I 13.3:

"The label must bear the following particulars:
(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;"


Shimon

 

[HnZul]

Hi thenewbiemdr,

1. The MDR defines 'label' as:
‘label’ means the written, printed or graphic information appearing either on the device itself, or on the packaging of each unit or on the packaging of multiple devices;"

To your question - the EU rep info should appear on the device label or the immediate packaging.

2. The MDD which is the current regulation says the following in Annex I 13.3:

"The label must bear the following particulars:
(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;"


Shimon

Hi Shimon,
So is it safe for me to say the EU Rep information is not a mandatory to be printed on primary pack (single unit pack). Instead we print them on inner box label?