Medical Device Re-Labeling question - Customer has modified the labels

#11
:confused: I'm not quite sure where to post this. Hope this is acceptable. We package and label (all levels) a product for a customer then send product for sterilization. Product is then shipped from sterilizer to customer.

However, customer has modified the labels (added a new CE mark) and would like us to print them and send to them so they can re label the finished sterilized product.

I don't know how to control this so open to any suggestions including direction to a reg/other that might tell me this can't be done.

Thanks very much in advance.
They cannot just put their own CE mark on another manufacturer's product, there are steps they need to take.

It sounds to me like they want to be Own Brand Labellers, and they would have to approach their NB for review to enable them to get certification and to be able to use their NB's no. Under the EC Directives, they would become the legal manufacturer.

Look to 60601-1 for the definition of 'manufacturer' and that should help you to understand this a little more.
 
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#12
I would also like to add this:

I don't know how to control this so open to any suggestions including direction to a reg/other that might tell me this can't be done.
What they do, is not your responsibility.

If they ask you for a label for any product with their name and address and CE mark, there is nothing stopping you supplying them. It is their label and they are responsible.

If however they ask you for a label with your name and address on and their CE mark, then you must refuse to do that. You cannot legally produce labels with your company name and address using anyone else's CE mark.

I hope that is more clear. :)
 
M

MIREGMGR

#13
What they do, is not your responsibility.

If they ask you for a label for any product with their name and address and CE mark, there is nothing stopping you supplying them. It is their label and they are responsible.
Just a further comment on responsibility as a matter of law:

Responsibility is determined by a business agreement.

If your business agreement...Purchase Order, contract or whatever...says that you are regulatorily responsible for the products, then in my legal understanding you are not absolved from responsibility for their labeling actions...especially if you enable those actions by providing materials.

If you are regulatorily responsible, then you are obligated to generally ensure that when your products reach the end users, those products are fully conformant with applicable regulations and directives, including proper labeling.

You are only absolved from responsibility for a customer's labeling actions if your business agreement with them makes clear that they are regulatorily responsible for the products, not you.

If your business agreement doesn't address regulatory responsibility, then by default you are responsible.
 
#14
Responsibility is determined by a business agreement.
No law determines responsibility.

If your business agreement...Purchase Order, contract or whatever...says that you are regulatorily responsible for the products, then in my legal understanding you are not absolved from responsibility for their labeling actions...especially if you enable those actions by providing materials.
No. The law is law.

If you are regulatorily responsible, then you are obligated to generally ensure that when your products reach the end users, those products are fully conformant with applicable regulations and directives, including proper labeling.
You are only absolved from responsibility for a customer's labeling actions if your business agreement with them makes clear that they are regulatorily responsible for the products, not you.

If your business agreement doesn't address regulatory responsibility, then by default you are responsible.
How can you post such .................?
No business agreement can override any law.

Nobody can be absolved from legal responsibility by any business agreement.
 
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A

Al Dyer

#15
Jeez,

If you print the labels get a contract modification and a date when that modification takes affect and ship to that modification.

If they send the labels get a modification noting so.

Above all, work with the customer to ensure the proper conversion applies. This concerns me in that regulatory/sterilization possibilities (medical supplies?) exist. More Info???

Al...
 
M

MIREGMGR

#16
No law determines responsibility.

No. The law is law.

How can you post such .................?
No business agreement can override any law.

Nobody can be absolved from legal responsibility by any business agreement.
I'll try to clarify.

I'm sure we agree that every medical device has one party with primary regulatory responsibility.

Scenario A: I manufacture a device myself, I properly apply my CE Mark to it, and I market it. I'm regulatorily responsible for it.

Scenario B: I contract with another company (a "contract manufacturer") to physically make a device for me, then I properly apply my CE Mark to it (or have the contract manufacturer apply my Mark for me, or provide me with labels containing my Mark that I will apply), and I market it. I'm regulatorily responsible for it.

Scenario C: Like Scenario B, but the company that physically makes the device also separately markets it under their own name, with their own CE Mark.

Scenario D: The company that physically makes the device applies their CE Mark. I buy the device from them and market it as a distributor...that is, it remains labeled with their CE Mark and with them identified as the regulatorily responsible manufacturer.

My understanding of medicalcomp's posts earlier in the thread is that they originally thought that their business arrangement with their customer was Scenario D. Either the customer changed their mind, or there wasn't a meeting of the minds in the first place, and now the customer wants to proceed according to Scenario B.

My point was that in any medical device dealing, it should be clear that both parties have the same understanding of which scenario applies. None of the major medical device regulatory systems...the EC's or the US or Canadian systems...prevent such confusion as a matter of law, though they have elements that attempt to govern what happens if things go wrong. To avoid the applicability of those rules, it makes sense for the parties involved in any such relationship to have an agreement that they identically understand.
 
#17
Thank you.

My point was that in any medical device dealing, it should be clear that both parties have the same understanding of which scenario applies. None of the major medical device regulatory systems...the EC's or the US or Canadian systems...prevent such confusion as a matter of law, though they have elements that attempt to govern what happens if things go wrong. To avoid the applicability of those rules, it makes sense for the parties involved in any such relationship to have an agreement that they identically understand.
The QSR, CMDR and MDD all state what's required in law. There is a slight difference between the requirements of the QSR, CMDR and MDD, but nothing that changes where legal responsibility lies at all times.

I am guessing here, because I'm a little confused. Are you saying that it is a good idea to tell a customer, by written agreement, where that customer is going to take full legal responsibility for your product?

This is why I am confused: If a customer is going to take legal responsibility for any product, they should themselves be aware of anything that's required by them without the need for an agreement to confirm what is already written within the QSR/CMDR and MDD.
 
M

medicalcomp

#18
Grateful for all the replies. The one question that popped out is who owns CE Mark. They do. We simply print the labels with their name and now, with their CE Mark, per their new artwork.

So, it seems that they are responsible, but we have to have proper records of new labels sent to them as well as documentation stating what they are going to do with them, etc.

It appears there are no formal rules that apply to this other than regulatory responsibility agreements.
 
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