CE Mark - Company out of Business

Q

QM Becky

#1
Hello Folks,
Got an interesting question today. I think I know the answer, but need some confirmation (or discent).


Scenario:
  • Acquisition of a company with CE marked products
  • No current CE mark with my company
  • CE mark will be in place with my company before the end of the year
  • Acquisition provided 5 months inventory for the shelves that we can sell until we are up and running in production and have our CE mark for that production.
Question:
  • Do old company CE marked products need to be relabeled?
My contention is NO for 2 reasons:
1) I can not put my CE mark on them as they were not manufactured under my quality system and not under my CE mark approval
2) the CE mark belongs to the product, not the company, and therefore the products that were manufactured at the acquired company were manufactured under a CE compliant system and the products are "approved" for sale as CE marked.

I like to use the wal-mart theory on this one... if Panasonic were to go out of business, wal-mart would not be required to pull the inventory they already purchased from Panasonic for sale... they would continue to sell until their inventory ran out. Same situation in my opinion.

Need some other thoughts on this one.

Thanks!
 
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chris1price

Trusted Information Resource
#2
I would agree with you, on condition that 1) you have all the technical files relating to the product and 2) you continue to perform post market surveillance activities (complaint, recall, etc) on the product.

However, I would also discuss it with the Notified Body of the old company and if possible with the new NB for your company and get their agreement on what is happening.

Chris
 
Q

QM Becky

#3
Thanks Chris, you have confirmed my thoughts. We have the tech files and have just about completed the updates to them to reflect the new business and updated procedures. We've already got processes in place to conduct all post market surveillance activities including a full review of the old company's surveillance, clinical assessments and complaint histories.

I've spoken to both my NB (who will be certifiying us) and the previous NB and both seem to be in agreement. Its the old company who is giving me grief. I think we are ok, but wanted to get my opinion validated as well as see if anyone had been through this and had some experiences.

Thanks for the quick response!
 
M

MIREGMGR

#4
Will you be selling that prior-manufactured inventory as (in effect) a Private Label Manufacturer, since your company didn't manufacture it and didn't own the OEM Manufacturer at the time of its manufacture, and the inventory (I assume) is labeled with the OEM Manufacturer stated as Manufacturer?

Its the old company who is giving me grief.
What is their objection or concern?
 
Q

QM Becky

#5
Will you be selling that prior-manufactured inventory as (in effect) a Private Label Manufacturer, since your company didn't manufacture it and didn't own the OEM Manufacturer at the time of its manufacture, and the inventory (I assume) is labeled with the OEM Manufacturer stated as Manufacturer?


What is their objection or concern?
The prior manufactured product will remain with the old company lableing/information. We do own the company throughout the final production, and they are staying 'open' until inventory levels are as agreed upon in the terms of sale. Basically, we purchased them with a specific inventory level target.

Their concern is not quite clear. They seem to be hung up on the idea that "their CE" mark isn't valid once the company is no longer a legal entity. The arguement back is the fact that they don't "own" the mark, they own the system that supported the mark, but that the mark belongs to the product once manufactured and represents the conditions under which it was manufactured.
 

somashekar

Staff member
Super Moderator
#6
The prior manufactured product will remain with the old company lableing/information. We do own the company throughout the final production, and they are staying 'open' until inventory levels are as agreed upon in the terms of sale. Basically, we purchased them with a specific inventory level target.

Their concern is not quite clear. They seem to be hung up on the idea that "their CE" mark isn't valid once the company is no longer a legal entity. The arguement back is the fact that they don't "own" the mark, they own the system that supported the mark, but that the mark belongs to the product once manufactured and represents the conditions under which it was manufactured.
The old company is now your company in all respects, legal, financial, management, QMS, regulatory and whatever else. So the old company regulatory chief is obligated to communicate this to the NB and introduce you (or the new regulatory chief in case) to the NB and mention a cutoff date and the cut off batch No, Sl number etc of all the listed products. This is a significant change and the NB will decide to take a call on an interim MDD audit if they so desire to. You are obligated to provide all post market services and support to the already placed products in the market and this communication also needs to be sent to the NB. It is a good practice to continue with the same NB unless otherwise you have valid reasons to change.
 
Q

QM Becky

#7
It is a good practice to continue with the same NB unless otherwise you have valid reasons to change.
Good Points. We were originally scheduled to have the same NB (our ISO certificate is with the same NB) however, when it came down to the timing, costing and general working relationship we decided that the former NB (our former as well) we were unwilling to continue to deal with the excessive costs, lack of communication and generally poor customer service. Our new NB is fully aware of the situation and will be auditing us in a few weeks. The old NB has been notified of the change and the official notice of change has already been submitted.

I think we've done everything right, and I think my assertion is correct. Can anyone see where it may be flawed?
 
M

MIREGMGR

#8
The CE Mark isn't the basis for legal sale of the products in question...the Certificate is.

Under the MDD, in my understanding, products are not legally presumed to be compliant if their responsible Manufacturer is no longer Certified, irrespective of whether the Manufacturer was Certified when they were made and irrespective of whether they carry the CE Mark. Products that already have left the control of the Manufacturer are in an undefined legal state, not meeting the legal requirements for marketing but also not having a specific legal framework established for their recovery from the market.

Under my company's contract with our NB (paraphrasing), any change in the ownership, legal structure or operating status of our company is required to be communicated to the NB immediately. Failure to do so results in immediate Certificate termination. Our NB also may decide that the Certificate is to be terminated per that change.

In the instance of termination, we are contracturally required not only to cease application of the CE Mark, but also to remove it from any already-manufactured product in our possession or control.

Assuming that your circumstances are similar and the contract in your instance has similar provisions, if you have the other company's NB's agreement that the other company's CE Certificate remains in force, then you're good to go.
 
Q

QM Becky

#9
In the instance of termination, we are contracturally required not only to cease application of the CE Mark, but also to remove it from any already-manufactured product in our possession or control.
Your comments pose an interesting possible legal loophole. Since the contractual obligation is to remove the CE mark from any already manufactured product in your possession or control, what would you do with products sold to a distributor or to a kit packer or other warehouse type operation that wasn't the final hospital? Would you issue a recall for those products? Seems a bit outside the scope of the intent. I go back to the idea that once the product is sold, assuming no recallable incident, the product is sold. The customer, whether it be a hospital or distributor or a wal-mart (I use wal-mart to describe any other store) can sell what they rightfully own. (assuming they have the right permits, licensing, etc.. to sell it to begin with)

That being the case, since we are the distributor at this time, and we have rightfully purchased inventory that is being manufactured and sold while the previous company is still legitimately open and compliant, I see no reason to change anything on the shelf at the time they close.

What am I missing? :confused:
 

somashekar

Staff member
Super Moderator
#10
Your comments pose an interesting possible legal loophole. Since the contractual obligation is to remove the CE mark from any already manufactured product in your possession or control, what would you do with products sold to a distributor or to a kit packer or other warehouse type operation that wasn't the final hospital? Would you issue a recall for those products? Seems a bit outside the scope of the intent. I go back to the idea that once the product is sold, assuming no recallable incident, the product is sold. The customer, whether it be a hospital or distributor or a wal-mart (I use wal-mart to describe any other store) can sell what they rightfully own. (assuming they have the right permits, licensing, etc.. to sell it to begin with)

That being the case, since we are the distributor at this time, and we have rightfully purchased inventory that is being manufactured and sold while the previous company is still legitimately open and compliant, I see no reason to change anything on the shelf at the time they close.

What am I missing? :confused:
It is here that care has to be exercised when you inform the NB about the closing batch number / product Sl. number of all the listed products, and the date at which the change is effected.
 
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