OEM branding - My interpretation of the LVD Directive makes us a manufacturer

#1
Good morning to you All!

This forum is amazing!

I am really hoping someone could help in providing me with the answer.

There is a manufacturer who owns the design, manufacturing and my company wants to distribute their product into EU under Low Voltage Directive. The sticking point is the branding. The intention of my company is to have our branding on it what in my interpretation of the LVD Directive makes us a manufacturer. I have read LVD Directive and:
Article 13 of 2014/35/EU (Low Voltage)

Any economic operator that either places electrical equipment on the market under his own name or trade mark or modifies electrical equipment in such a way that compliance with this Directive may be affected should be considered to be the manufacturer and should assume the obligations of the manufacturer.


....also Blue Journal states as follows

Official Journal of the European Union C272
3.1 Manufacturer

- The manufacturer is any natural or legal person who is responsible for designing or manufacturing a product and places it on the market under his own name or trademark ( 91). The definition contains two cumulative conditions: the person has to manufacture (or have a product manufactured) and to market the product under his own name or trademark. So, if the product is marketed under another person's name or trademark, this person will be considered as the manufacturer.

- The manufacturer has ultimate responsibility for the conformity of the product to the applicable Union harmonisation legislation, whether he designed and manufactured the product himself or is considered as a manufacturer because the product is placed on the market under his name or trademark.



Please, are you aware of any other interpretations, recommendations that would allow the Company B distribute the product (Company A is the manufacturer) when adding own brand to the instrument? To me it looks pretty much black and white and makes Company A a manufacturer but I am also aware of the IVDR clauses (we also operate in the IVD industry - not the product I have mentioned in this topic) where:

Article 16 IVDR 2017/746 (IVDR)

Cases in which obligations of manufacturers apply to importers, distributors or other persons

A distributor, importer or other natural or legal person shall assume the obligations incumbent on manufacturers if it does any of the following:
(a) makes available on the market a device under its own name, registered trade name or registered trade mark, except in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in this Regulation;



At the same time I couldn't find anything similar in the current IVD Directive.

Do any exceptions or recommendations exists? Maybe the interpretation is different?

Please may I ask for your opinion?

Regards,
 
Elsmar Forum Sponsor
#3
Hi,
It's an electrical equipment to be used in laboratory (IEC61010-1) under the Low Voltage Directive (not a medical device or IVD)
 
#4
My understanding is that under EN61010 you are correct in that you would be considered the manufacturer from the position of the EU.

There is no problem from the EU point of view in you doing this, the actual product builder simply gets treated the same as a subcontractor building product at your behest. If your get the product fully branded with your branding then its YOURS! you are the manufacturer. the original company is making the product for you only and only you can sell it though your sales channel.

If you do not wish to become the product manufacturer then you would need to declare the name of the actual manufacturer separately on the product in such a way as to make it plain you are declaring them to be the manufacturer. In a previous company we needed to make such a declaration as our distributor within the EN was not prepared to take on the responsibility of the manufacturer and give the product was made in the EU there was no importer. note the liabilities of the importer and manufacturer are very similar so you do not gain much be being and importer rather than the manufacturer.
 
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