Greetings Nesli,
Under the EU MDR private labelling is difficult. If you want to trademark a product, use a different brand/trade name, a product logo, colours on the package, etc., this can all be done. What is most important is who is identified as the Manufacturer (legal manufacturer) on the product labelling - the name and address next to the little factory symbol.
If your company trademarks a product, uses your brand name, but then put your company name as Manufacturer you are fully responsible for the regulatory compliance of the product. The different company would then be a supplier/contract manufacturer where you will need full access to the Technical Documentation. A contract would need to be in place between the two companies allowing access to Technical Documentation.
If your company trademarks a products, uses your brand name, but the other company's name is shown as the Manufacturer then they are still responsible for the regulatory compliance of the product. And then in essence your company could be a distributor. As you can imagine there would need to be a contract and/or business agreement in place between the two companies regarding trademarking and distribution.
So in answer, you can do both, but if your company goes through a Notified Body to get CE Marked, the access to the original Technical Documentation must be available.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 10-Feb-2022 04:39
From: Peter Miko
Subject: Trademark/Legal Manufacturer
Dear Nesli,
I think assigning a new trademark to an existing device of another manufacturer creates a new (2nd) brand, which requires a new legal manufacturer (and CE-marking procedure) before its lauch.
regards
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Peter Mikó M.D
ArtPharm Ltd.
Gyermely
Hungary
Original Message:
Sent: 10-Feb-2022 04:24
From: Nesli Karakaya
Subject: Trademark/Legal Manufacturer
Dear Adam,
thank you very much for your response. The focus of my question was trademarking under our company name of a product that we are just distributor. Definition of "Manufacturer" per MDR includes the trademarking as well.
Best Regards
Nesli
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Nesli Karakaya RAC
Director Regulatory Affairs
Bougy -Villars
Switzerland
Original Message:
Sent: 10-Feb-2022 04:09
From: Adam Gregory
Subject: Trademark/Legal Manufacturer
Dear Nesli,
Providing the legal manufacturer is based in the EU or has a suitable EC REP if based outside the EU then you will not need to have the devices you intend to market approved by your NB as a general rule. There will need to be some consideration on items such as economic operator requirements amonst other MDR requirements such as vigilance which would need to be clearly defined in legal agreements between the two entities. One thing to consider which is a focus for devices which require a design examination (Annex IX Sec. 4), Notified Bodies often require that the Brand Names, Catalogue numbers etc of these products are listed on the Design Examination Certification so you would need to ensure your brand is captured on these certificates under MDD and MDR to distribute.
Hope that helps,
Adam
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Adam Gregory
Regulatory Affairs Manager
Winsford
United Kingdom
Original Message:
Sent: 09-Feb-2022 04:48
From: Nesli Karakaya
Subject: Trademark/Legal Manufacturer
Dear all,
We are planning to distribute and trademark a product. Legal manufacturer is a different company. Do we need to have the product CE marked under our NB and therefore will have to have all MDR requirements met (i.e., PMS, risk, etc.) or can we keep the current legal manufacturer and we continue as a distributor.
Thanking you in advance.