A
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
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
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?"
I just had a "didn't think" moment.