Relabeler EU from USA

Q

QARAM

#1
Odd question perhaps, but most relabeling questions seemed to come because of the FDA. This one may be different.

My company is a manufacturer in the USA who owns the CE-mark. We want a European company to distribute the product as the manufacturer instead. We do not need them to distribute in the USA.

What do we need to do to accomplish this? I was thinking they would need to obtain their own CE-mark. If so, is there an easy way to do this, like telling the notified body that all processing, labeling, packaging, specifications, etc. is identical, except the Manufacturer name?

I don't believe we need to do anything for the FDA unless our company needs to register as a relabeler (even though we are the OEM). I don't believe the European company would need to do anything for the FDA. Let me know if that thinking is incorrect.

Thanks!
 
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pkost

Trusted Information Resource
#2
If you want your distributor to be declared as the manufacturer in the EU then they must comply with the requirements of the directive and CE mark product themselves.

There is a "quicker/easier" route to market in this case as you have a CE mark in place - it is known as own brand labelling and essentially boils down to the distributor saying "My device is safe and effective because it is identical to this one which already has a CE mark (and is therefore safe and effective). They will still need to appoint their own notified body to do this (assuming >ClassI) - there are plenty of other threads on this forum that go into the necessary detail
 

robert.beck

Involved In Discussions
#4
If you want your distributor to be declared as the manufacturer in the EU then they must comply with the requirements of the directive and CE mark product themselves.

There is a "quicker/easier" route to market in this case as you have a CE mark in place - it is known as own brand labelling and essentially boils down to the distributor saying "My device is safe and effective because it is identical to this one which already has a CE mark (and is therefore safe and effective). They will still need to appoint their own notified body to do this (assuming >ClassI) - there are plenty of other threads on this forum that go into the necessary detail
It would be most helpful if you could point out the names, keywords, titles, etc. of these 'plentiful' other threads. I am going try to find them and if successful, I will post some of there here. I am not stupid or lazy, and I find this kind of generic comment to be of low value when I'm trying to find something quickly.
 

robert.beck

Involved In Discussions
#5
It would be most helpful if you could point out the names, keywords, titles, etc. of these 'plentiful' other threads. I am going try to find them and if successful, I will post some of there here. I am not stupid or lazy, and I find this kind of generic comment to be of low value when I'm trying to find something quickly.
ok, it's a couple of hours later, and I have found that there is a category of distributor called "Own Brand Labeller" (OBL) which is now called a virtual manufacturer in the UK. a guidance on the latter is attached. whether this is a better route that just hiring a distributor remains to be determined.
 

Attachments

Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#6
ok, it's a couple of hours later, and I have found that there is a category of distributor called "Own Brand Labeller" (OBL) which is now called a virtual manufacturer in the UK. a guidance on the latter is attached. whether this is a better route that just hiring a distributor remains to be determined.
This thread is more than 4 years old and that may be why you hadn't gotten a response.
 

pkost

Trusted Information Resource
#7
Hi Robert,

As you have established for yourself, obl doesn't really exist as an option anymore. Manufacturers were taking advantage of it and regulators have taken a stricter interpretation of the directive.

While I'm sure you are perfectly capable and not lazy, I would like to point out that I wrote my response in my free time for no personal benefit, I recounted my experience and gave sufficient information to get the OP started on their journey. If I find a topic interesting and one that requires me to do some research for my own learning then I would provide links and references

I'm sorry that you found my comment to be generic and of low personal value, it seemed to satisfy the OP at the time, and if he had asked follow up questions I would have helped further, assuming of course that he appeared to appreciate my help and didn't act like he had a right to my immediate response
 

Ronen E

Problem Solver
Staff member
Moderator
#8
I am not stupid or lazy, and I find this kind of generic comment to be of low value when I'm trying to find something quickly.
I'm writing this response under two hats - first as a member volunteering here to help others, and second as a moderator.

Under both hats I find this remark unnecessary and a bit destructive, and under the first maybe even a bit offensive.

If you find something posted here too generic or of low value to you - just ignore it. Stating that a subject has been discussed in Elsmar without serving the relevant threads on a silver platter is not necessarily saying that anyone is "stupid or lazy", and might still be helpful. Some people have been around here for a long time so they remember such threads exist, while it might not be obvious to newcomers. Helping here is voluntary, no one gets paid for it, so it's only natural that each one of us helps to the extent we each feel is appropriate for us. Last, the fact that you're trying to find something quickly isn't relevant at all to any discussion here. If someone happens to match you're needs in a specific situation that's great, but if not then that's it. That's the nature of a voluntary forum where help is delivered free of charge.
 
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