Ownbranding or placing on market without CE mark

A

Asherlee

#1
Hi,

A distributor or manufacturer of medical devices (whom we will call company “A”) wishes to buy an OEM device from a manufacturer (whom we will call company “B”). Company “B” obtained CE marking for the device under its own name and label.

Company “A” wants to sell the device (place it on the market) under its own name and label. According to the MDD, company “A” becomes the legal manufacturer and has to apply for CE marking in its own name as an ownbrander or own labeler. However, for commercial and other reasons, company “A” does not want to apply for CE marking in its own name (for example, company “A wants company “B” to provide service for the device).

Solution? A possible way of overcoming this issue is for the ownbrander (company “A”) to exclusively license back the right to use their trademark, in respect of the device in question, to the original maker of the device to the exclusion of all others. In this way depending upon the precise terms of the licensing agreement, the maker of the device could become the "manufacturer" as defined in the Regulations.

Is the above solution feasible from a regulatory, contractual and marketing perspective? If not, does the forum have any other ideas as to how to tackle this issue?

Thanks a lot.

Asherlee
 
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Wes Bucey

Quite Involved in Discussions
#2
That proposal is clever and has a certain logic to it. I'm eager to find out if it works.

Shortfall I predict:
Labeling must be clear and precise as to who is responsible for device. The reason distributors do not require registration to ISO13485 in some markets is that their name is not on the label. Ergo, when a problem arises, folks go back to the manufacturer.

:topic: Although you say it is off topic, I am VERY curious about the reasons that an organization would find your proposal more attractive than simply applying for CE and entering into a simple service contract with the original manufacturer to take responsibility for service while company A retains liability on the label. (i.e. the label says, "for service, please send to our service department: "Company A [at Company B's address]") Same with the 800 toll free phone - answered by special operator at Company B with "Company A. How may I help you?"
 

Al Rosen

Staff member
Super Moderator
#3
Regardless of any business license, according to the MDD:
manufacturer means the natural or legal person with responsibilityfor the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.

The obligations of this Directive to be met by manufacturers also apply to the natural or legal person who assembles, packages, processes, fully refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name. This subparagraph does not apply to the person who, while not a manufacturer within the meaning of the first subparagraph, assembles or adapts devices already on the market to their intended purpose for an individual patient.
I doubt from what you described, company A does not fall within this definition especially considering its name is going on the device.

Though you may ignore the facts, they still remain.
 
Last edited:

Wes Bucey

Quite Involved in Discussions
#4
:bonk: I just had a "didn't think" moment.

Obviously, there is a political factor here which I didn't pick up on at first because I was too narrowly focused on the CE question.

The political question has to be resolved (the reason company A does not want company B to appear on the label) before anything else can proceed. The other stuff about not wanting to do the service is "fog." This whole scheme is about hiding Company B's involvement in the product from the intended market.
 

Al Rosen

Staff member
Super Moderator
#5
Wes Bucey said:
:bonk: I just had a "didn't think" moment.

Obviously, there is a political factor here which I didn't pick up on at first because I was too narrowly focused on the CE question.

The political question has to be resolved (the reason company A does not want company B to appear on the label) before anything else can proceed. The other stuff about not wanting to do the service is "fog." This whole scheme is about hiding Company B's involvement in the product from the intended market.
Regardless of the reason, the authorities want to know who is responsible for placing the device on the market. This is universal. The person or entity must be named on the label and must meet the requirements of the MDD. One of the requirements is placing the CE mark along with the Notified Body's identification number. To be allowed to CE mark, you must meet the essential requirements along with requirements determined by the class of the device. Annexes II, through VII describe these requirements.

The MDD can be found in this post.
 
R

r.daling

#6
Similar situation

We had a similar situation where we wanted to sell a product from another manufacturer under our own product name. We were able to get a "multiple listing" where the product was approved based on the other manufacturer's original approval. It required some cooperation from the other company, but saved a heck of a lot of time and money. We are operating in Canada - not sure what other countries do, but it might be worth looking into.
 

Wes Bucey

Quite Involved in Discussions
#7
Neither Canada nor USA require CE mark. Canada, as of March 2006, will require medical device manufacturers to be registered to ISO13485 (manufacturers, not distributors.)

USA, of course, operates under FDA, a whole different ball game.

We are talking here about playing within the rules of the market where we want to sell.
 
R

Roland Cooke

#8
I deal with a lot of OBL queries, especially when it comes to manufacturer identification. Usually the problem is everyone wanting their name and address on the box, which can cause confusion. But wanting to avoid having your own identity on the box seems very strange to me. The whole point of the OBL system is to enable companies to make do with little or no regulatory resource.

Own-brand labelling is essentially a form of subcontracting, nothing more. The regulatory leg-work has been farmed out, but the responsibility can never be delegated.

My rule of thumb? Is it clear who is going to prison? :D Whoever's name is on the box is considered to be the legal manufacturer and needs to make a Declaration of Conformity, that is the legal requirement, end of story.


Having said all the above, it should be noted that the wording of Asherlee's plan is lifted straight from the MHRA guidance on their (new) website, thus I guess they think it is okay..... :cool:

http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON009813



But I personally think it is fraught with problems. :mg:
 
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