Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

​In regards to the new Importer responsibilities, including labeling, in the EU MDR.  Does anyone have an opinion whether it would be acceptable for a manufacturer to include the importer's name, contact information (and new importer symbol) on the product labeling prior to the product entering the EU, if the Importer was wholly owned by the manufacturer?  Or does this activity need to be conducted in the EU by the importer?

Thanks

This message was posted by a user wishing to remain anonymous

This is how we intend to do this via contracting this responsibility to our manufacturing site from our EU Importer.  As long as the linkage is handled appropriately via our QMS, I don't see why it wouldn't be acceptable.
Original Message:
Sent: 10-Sep-2018 14:57
From: Anonymous Member
Subject: MDR Importer Responsibilities

This message was posted by a user wishing to remain anonymous

​In regards to the new Importer responsibilities, including labeling, in the EU MDR.  Does anyone have an opinion whether it would be acceptable for a manufacturer to include the importer's name, contact information (and new importer symbol) on the product labeling prior to the product entering the EU, if the Importer was wholly owned by the manufacturer?  Or does this activity need to be conducted in the EU by the importer?

Thanks

Hi,

within the MDD i had such discussions regarding the placement of the fileld factory symbol - the one that states who is the legal manufacturer.
Based on those discussion i would assume that it is possible but important to clearly show who is the legal manufacturer.

In that case it should be the importer.
Still it is possible to place any other names on the labels from other manufacturers or distributors.
Important is though that the placement of symbols and names must not lead to irritation but show clearly who is the legal manufacturer.
For example you should not place two names or addresses besides the factory symbol (same goes for other symbols), and of course use only one symbol of a type on the label.

------------------------------
Sven Schaumann
Dipl.-Ing. Electrical Engineering
Freelance Consultant
https://www.med-engineering.de
Potsdam, Germany
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Original Message:
Sent: 13-Sep-2019 14:36
From: Anonymous Member
Subject: MDR Importer Responsibilities

This message was posted by a user wishing to remain anonymous

This is how we intend to do this via contracting this responsibility to our manufacturing site from our EU Importer.  As long as the linkage is handled appropriately via our QMS, I don't see why it wouldn't be acceptable.
Original Message:
Sent: 10-Sep-2018 14:57
From: Anonymous Member
Subject: MDR Importer Responsibilities

This message was posted by a user wishing to remain anonymous

​In regards to the new Importer responsibilities, including labeling, in the EU MDR.  Does anyone have an opinion whether it would be acceptable for a manufacturer to include the importer's name, contact information (and new importer symbol) on the product labeling prior to the product entering the EU, if the Importer was wholly owned by the manufacturer?  Or does this activity need to be conducted in the EU by the importer?

Thanks