CE Mark - Company out of Business

M

MIREGMGR

#11
I agree with Somashekar on the utmost importance of having the agreement of the other company's NB with whatever you will do.

(...) since we are the distributor at this time (...)
While you would be the Distributor under US FDA rules if such applied, you may be the Private Label Manufacturer under MDD. Responsibilities are quite different between the two cases. A good guidance regarding OEM vs. PLM is provided at http://www.zlg.de/download/ab/309_0607_B16EN.pdf.
 
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somashekar

Staff member
Super Moderator
#12
Just an other question sir ...
Would the name and address of the manufacturer undergo a change with this transaction ?
In case it is not (and I hope it is not) then the change of management can be informed to the NB being a significant change and then you would have a smooth continuation. Your legal and business process should not greatly effect your CE mark, as long as the regulatory responsibilities are correctly handed over and ownership taken.
 
Q

QM Becky

#13
Just an other question sir ...
Would the name and address of the manufacturer undergo a change with this transaction ?
In case it is not (and I hope it is not) then the change of management can be informed to the NB being a significant change and then you would have a smooth continuation. Your legal and business process should not greatly effect your CE mark, as long as the regulatory responsibilities are correctly handed over and ownership taken.
The products that were previously manufactured (that we purchased and are on the shelves) woudl maintain their current labeling (approved by the NB). They have been updated to reflect our address as the "manufacturer" to meet the requirements of the MDD (the "quasi-manufacturer" situation). The change in management has been made known to the NB. The NB seems to be on board, it's the company I'm having issues with. Part of me wonders if I should really care about their issues since the NB is ok with it, and they will cease to exist, maybe I should just ignore them for now and wait out the storm! :D
 
M

MIREGMGR

#14
It's not clear how they can be objecting if their NB is listening to you rather than them, and if their product labels are being revised by you. If they're paying their NB, why is that NB listening to you? If you have bought them, on what basis are they objecting to your decisions?

Too many cooks spoils the broth.
 
#15
Only the manufacturer of the product can use the CE Mark with their own NB number.


MDD Definition of Manufacturer - The natural or legal person with responsibility for the design, manufacture, packaging and labeling 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.
 

somashekar

Staff member
Super Moderator
#16
The products that were previously manufactured (that we purchased and are on the shelves) woudl maintain their current labeling (approved by the NB). They have been updated to reflect our address as the "manufacturer" to meet the requirements of the MDD (the "quasi-manufacturer" situation). The change in management has been made known to the NB. The NB seems to be on board, it's the company I'm having issues with. Part of me wonders if I should really care about their issues since the NB is ok with it, and they will cease to exist, maybe I should just ignore them for now and wait out the storm! :D
The CE as such belongs to the NB and since NB and you are on the same level, I feel you need not put time and effort with the OLD company. If the business transaction with them is complete and you now have all the absolute management controls, you can request them to stay out and let you manage.
Good Luck Sir ...
 
Q

QM Becky

#17
Well, it's all going to be solved in about an hour. The discussions finally came to a head and I'm tired of wasting my time discussing it with them. SOO, we are talking with the NB, together, today so that the old company can hear first hand what the NB told me and quite questioning my ability to research, evaluate and decide. I'll let you all know how it turns out!

Thanks for the discussion and the points to think about.
 
Q

QM Becky

#18
The verdict is in... Old company may now sit down.

Thank you everyone for the conversation and the items to think about. I pride myself on doing my research and not making recommendations or decisions without sound reason. Being questioned so brutally, when I knew I had my bases covered, was both satisfying and frustrating at the same time. I appreciate having a forum like this to bound ideas off of, and engage in intelligent discussions with. Thank you to everyone who helped!
 
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