Europe import Regulations? Customers are requesting us to sign OEM/ODM Agreements

[Natylatte]

My name is Natalie. I'm from a wheelchair factory in China and currently we are facing a trouble with some European customers.
These days, few European customers are requesting us to sign OEM/ODM agreements with them. Specially one German customer who sent us an OEM agreement few days ago, claiming that we must sign for them, otherwise the German government won't let them sell our products in their market (situation which is happening in all Europe => according to their statement). The fact is, our commercial relationship with this customer is not OEM but ODM (we own our designs and we manufacture their products with their brand). The content of their agreement is outrageous since it only protects their rights and not ours, not mentioning that they intent to encroach our designs as theirs. The CEO explained to me that, the original agreement was provided by the government and they only made some few modifications to it. Actually, considering the unreasonable content of this agreement, we have no intentions of signing it unless it is modified to our acceptable version, since any agreement with signature and company stamp is legally effective in any country, we are forced to be extremely careful about this. However, since our other customers are also requesting us to sign similar agreements at the same time, my question is, is Europe really requesitng all the sellers to have this OEM agreement in order to sell import products in Europe market? I can't find any related documentation or news on the internet which could prove the German customer's statement, but I can't also find something which could prove them wrong.
Please help... We need to clarify all these doubts before being able to discuss again with them about this agreement.
Thanks a lot for reading my message and I would really appreciate if someone could provide assistance for this matter.
Thank you!

[Stijloor]

A Quick Bump!

Can someone help?

Thank you very much!!

[pkost]

There are a number of circustances where you may have to sign an OEM/OBL agreement, but in these cases the contract can be written such that you do not have to disclose very much information to the other party.

If you are selling the products with your own name, you have a CE certificate and EC rep and the pack states that you are the manufacturer then you do not have to sign an OBL/OEM contract

If your distributors are putting their own name on the product and saying that they are the manufacturer then you will have to sign an OBL/OEM contract. It is very common for companies to do this in the EU but it is something that should be agreed by both parties, it is frequently refered to as own brand labelling.

If you all agree to the own brand labelling route then there is certain information that the distributor needs to see so that they can compile their own technical file for submission to their notified body so that they can apply their own CE mark. this is typically the essential requirements checklist and the clinical evaluation. The contract will usually state that all other information is confidential and will only be disclosed directly to the notified body or competent authority if it is requested, it will not be disclosed to the distributor.....the NB and CA rarely request the data.

There are quite a few threads here about own brand labelling, if may be better to search for these instead of me detailing all of the possible scenarios

[Natylatte]

In Reply to Parent Post by pkost

the NB and CA rarely request the data.

Can I ask what is NB and CA?

To clarify our situation, we are selling our products to this German customer using their own brand. However, all the labels are printed here at China and placed on every product by us (including the CE marks, manufacturer info, etc). So, they are clearly not the manufacturer of the products. Our company's info is stated in every label on every product saying that we are the manufacturer of each product. The only thing that belongs to them is their brand. We own our design of our products. Therefore we cannot sign an OEM agreement which is too unfair for us (plus, there are too many unreasonable clauses in it).
So, I just want to know, is really the German government or any European government requesting every seller to have an OEM agreement in order to be able to sell products in the local market? Is this statement and requirement really exist?

I really appreciate any help and comments. Thank you!

[somashekar]

In Reply to Parent Post by Natylatte

Can I ask what is NB and CA?

To clarify our situation, we are selling our products to this German customer using their own brand. However, all the labels are printed here at China and placed on every product by us (including the CE marks, manufacturer info, etc). So, they are clearly not the manufacturer of the products. Our company's info is stated in every label on every product saying that we are the manufacturer of each product. The only thing that belongs to them is their brand. We own our design of our products. Therefore we cannot sign an OEM agreement which is too unfair for us (plus, there are too many unreasonable clauses in it).
So, I just want to know, is really the German government or any European government requesting every seller to have an OEM agreement in order to be able to sell products in the local market? Is this statement and requirement really exist?

I really appreciate any help and comments. Thank you!

If I am understanding you correctly, you are branding it with the customer product name, yet you appear as the manufacturer and the regulatory responsible for the CE mark on the product.
NB is your notified body who has authorized you to CE mark the product. I hope you also have put your NB number besides the CE.
If this is the scenario, your agreement will have to be purely a commercial agreement and not any regulatory agreement.
I do not know what ODM expands to, however I can see that you are not an OEM manufacturer for the European company just because you brand your product with his brand name.
If that agreement asks for anything unreasonable such as that you will not brand your product and market by any other name and such you are free to reject them.
If it is possible, can you share the agreement draft with us here ?
If your customer has an OBL CE, it is then always with your consent and your management and regulatory officer will know about this. Your label then will no longer have your name as manufacturer, and the European company will appear as the manufacturer, with his NB number along with the CE. This scenario is different and will have an OBL agreement between you are the European party, which your NB has reviewed and accepted.

[treesei]

In Reply to Parent Post by Natylatte

To clarify our situation, we are selling our products to this German customer using their own brand. However, all the labels are printed here at China and placed on every product by us (including the CE marks, manufacturer info, etc). So, they are clearly not the manufacturer of the products. Our company's info is stated in every label on every product saying that we are the manufacturer of each product.
I really appreciate any help and comments. Thank you!

"Made in China by xxx" on the label and that the label is printed in China may not mean that xxx is the manufacturer in regulatory context. I did not catch from the message the ownership of the CE marks.

[Natylatte]

In Reply to Parent Post by treesei

"Made in China by xxx" on the label and that the label is printed in China may not mean that xxx is the manufacturer in regulatory context. I did not catch from the message the ownership of the CE marks.

Well, on the label, it states clearly that we are the manufacturer of the product and our customer is the distributor of it. We put the CE marks and provide the Declaration of Comformity to our customer with all our info and our EU representative info on it.
However, my question is not based on the CE marks or who owns it.
I really need to know if European governments are requesting such OEM agreement for all distributors in order to let them sell on domestic market. Is this document really necessary? Thank you!

[MIREGMGR]

I really need to know if European governments are requesting such OEM agreement for all distributors in order to let them sell on domestic market.

The company for which I work has many European customers. We do OBL for a few, and others distribute our products. To specifically address the OP's question, I've heard nothing from any of them regarding any new governmental or regulatory requirements, from the German national government for instance. I haven't seen any discussion here by others of any such new requirements, either.

I'd guess that the distributor is just trying to gain business advantage over you, and that they have made up a "regulatory changes" cover story to justify their business-motivated actions.