Labeling question about different manufacturers on a single label

[Buddyz]

I had a question about labeling.

So, my company just started a new software design project where we would take an existing product and relabel it for the US (Manufactured for). For the rest of the world (EU specifically, so a CE mark), we are planning to be the manufacturer for the product (Manufactured by).

Initially, we were going to provide 2 separate part numbers and label it accordingly; however, my boss asked if we could do just 1 label with the manufacturing information on it to reduce the amount of part numbers. For my boss, this is important because there are roughly 40 part numbers if we separate out the 2 labels vs the 20 my boss proposed.

I have not seen where you would have 2 separate manufacturers on the label (one for the US as a relabeler, and one for the EU with a CE mark as a manufacturer). I also think it would be confusing. Has anyone seen something like this or experience this in your current labeling?

 

[Ed Panek]

My background is med device so not sure if my comment applies:

There is only one manufacturer of record. That company owns reporting responsibility to FDA, CE., etc.

I have seen companies use stickers to apply to the device in cases they want to be flexible on where it goes until the last moment, but if you are caught having two manufacturers of record it might be a problem.

Something to be aware of especially intl is customs takes labeling quite seriously and will hold shipments up if there are issues. I would not take shortcuts in labeling.

Are you using two IFUs?

 

[Buddyz]

Hi,
This is MDSW, so we can't change the labeling since this is embedded in the SW.

The IFU was initially going to be split with 1 dedicated for the US and 1 for the EU. Now that there have been talks about having one label, there is a consensus to have a single IFU.

We would be the manufacturer of record for EU. They would own it for the FDA.
Personally, I think there should be 2 versioning of the product, but wanted to see if people experienced a single label.

 

[indubioush]

Please do not label your product with one label. You must not label a product with the CE Mark until your product is approved. I doubt you will get approval from both locations at the same time. Do you really want to be in a situation where, for example, your product is labeled with CE mark but then has a warning about investigational use (or research use) only? Do you really want to have a label with multiple EU languages for your US users?

Why would there be 40 components just because you have a different label? You can have two different DMRs where the only difference is the label. Please clarify.

 

[Buddyz]

Please do not label your product with one label. You must not label a product with the CE Mark until your product is approved. I doubt you will get approval from both locations at the same time. Do you really want to be in a situation where, for example, your product is labeled with CE mark but then has a warning about investigational use (or research use) only? Do you really want to have a label with multiple EU languages for your US users?

Why would there be 40 components just because you have a different label? You can have two different DMRs where the only difference is the label. Please clarify.

You can time this if it's a class I device. Self declaration without NB involvement. We would release it with a change notice at the same time.

I did not say components. The product is unique that can work with many different medical devices, so there is a unique number for each separate medical device the product interacts with. This cannot be changed since the supplier is set-up this way.