How to obtain Own Brand Label (OBL) CE Marking?

  • Thread starter NicoleinFlorida
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Shonver

Starting to get Involved
#11
Our company is exploring the option that, from the above discussion, is best described by the "distributed by" model. Does this still make the company the official manufacturer (with the accompanying regulatory responsibilities)? I think that is what @RobertvanBoxtel is saying.

We intend marketing the European OEM's devices in Europe under our branding, while still retaining the OEM's details on the labeling. The intention is that there is a product bearing our name brand, but that the OEM would be otherwise responsible for the PMS and regulatory aspect. Their contact details, etc., will be reflected on the packaging.
 
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RobertvanBoxtel

Involved In Discussions
#12
@Shonver indeed if you plan to distributed the OEM products in the EU and the OEM is the holder of the CE certificates, they will be regulatory responsible. And they will have several requirements that you as distributor will need to meet. Now also in the new EU MDR and IVDR, there are clear requirements for the economic operators, including the distributors, see article 14. But maybe you are also the importer of the products. Also for that role, there are regulatory requirements, including registration in the upcoming EUDAMED database. Importer, only in the case the products are brought into the EU.
 

Ronen E

Problem Solver
Staff member
Moderator
#13
Our company is exploring the option that, from the above discussion, is best described by the "distributed by" model. Does this still make the company the official manufacturer (with the accompanying regulatory responsibilities)? I think that is what @RobertvanBoxtel is saying.

We intend marketing the European OEM's devices in Europe under our branding, while still retaining the OEM's details on the labeling. The intention is that there is a product bearing our name brand, but that the OEM would be otherwise responsible for the PMS and regulatory aspect. Their contact details, etc., will be reflected on the packaging.
If both companies are going to appear on the labelling you will have to clarify who is the official, regulatory-responsible Manufacturer. Both contractually between the companies, and to customers / users. Regulators will look at both aspects.
 

pkost

Trusted Information Resource
#14
The new MDR defines the brand owner and manufacturer - you specifically have to have a contract in place to pass responsibility back to the OEM

In the current MDD, although it is good practice and frowned upon if ignored, there is no specific requirement for an agreement
 

Shonver

Starting to get Involved
#15
So, to summarise (for my case):

1. Contract in place to clarify regulatory responsibility (is OEM) between us and OEM.
2. Own branding but (e.g.) "Manufactured by: [OEM details]. Only our trade mark, and no further reference to our company.

Will this be OK?
 

Ronen E

Problem Solver
Staff member
Moderator
#16
2. Own branding but (e.g.) "Manufactured by: [OEM details]. Only our trade mark, and no further reference to our company.

Will this be OK?
Still slightly misleading IMO. Especially if the trademark dominates the label. It's a matter of relative size, arrangement, colours etc.
 
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