Over-labelling the manufacturers name at the front of the device

JoCam

Trusted Information Resource
#1
Hi All,

If I was to purchase a class I medical device from the US to distribute in Europe would I be able to over-label the manufacturers name at the front of the device with my company's name, and change the product name by over-labelling? The OEM's name and address will still be on the label bearing the CE mark on the back of the device.

Jo
 
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rob73

looking for answers
#2
Re: Over-labelling

If the device is CE marked it take it the device is already on the market in the EU, if so then it may fall under "parallel imports".
https://www.gov.uk/government/publications/parallel-imports-of-medical-devices

If not you will need to be careful not to end up as the "manufacturer" under OBL rules.
Personally i would just add a "supplied by JoCam" label and leave the OEM's detail still on there.
Is there a big issue with leaving the OEM name on the packaging?
 

JoCam

Trusted Information Resource
#3
Re: Over-labelling

Thank you Rob,

I'm not sure if the device is being sold in Europe, so yes, you could be right and we may end up being a parallel importer.

We may want to remove the original manufacturer from everything except the on-product label that carries the CE mark. Can this be done, or can we only put our name on the device if we state that we are the distributor? Also, I'm concerned about changing the product name, as surely this is important for the CE mark.

I, personally, am with you on just adding our company name stating "distributed by", but need a standard or regulation to back this up before I break the bad news to the rest of the group.

Jo
 

JoCam

Trusted Information Resource
#5
Re: Over-labelling

Thanks again Rob, but we don't wish to go down the Own Brand Labelling road, so I suppose this means we should be affixing a "distributed by" label each time we apply a label with our company name on. I was wondering whether OBL could be avoided by keeping the original manufacturers details on the CE mark label alone.

Jo
 

rob73

looking for answers
#6
Re: Over-labelling

Yes, looking at your reply again it does seem to fall into a bit of a grey area as the device itself would not be changed, but saying that if you put your details and a CE mark you would surely be taking regulatory responsibility for the product?
Could it be regarded as a procedure kit?, which enable a "manufacturer" to put existing CE marked products into different packaging so long as the intended use is not changed.
There is a bit in the article.
http://www.emergogroup.com/blog/2008/05/are-you-considered-medical-device-manufacturer
 

JoCam

Trusted Information Resource
#7
Re: Over-labelling

Hi Rob,

We're not putting our name on the CE mark label, that will still carry the original manufacturers name and address. We don't wish to take regulatory responsibility for the device. I just need to know whether we can replace the manufacturers name in all other places on the device, and change their product name to include a product name of one of our devices.

Jo
 

rob73

looking for answers
#8
Re: Over-labelling

If the "outer" packaging does not have a CE mark then should be no issues, if however it does, it could be implied that you CE marked it, as just by looking at packaging you could not tell the device inside had a different manufacturer and CE mark.
Best thing to do is ask your certification body for clarification.
 

pkost

Trusted Information Resource
#9
I would be extremely cautious about over labeling product with your details, especially the product name. The product name is typically listed on the DoC and therefore intrinsic to the conformity of the product; similarly the company name, although this is slightly less of a concern if the "manufactured by" details aren't covered.

Distributed by stickers are quite common, although I have always seen them stuck over a non critical area


I would suggest if you want to do this, you work with the manufacturer for them to create the product in the form you would like, instead of trying to tread a fine line - there is nothing to stop them from manufacturing a product that references yours and contains more of your branding and less of theirs - it would also look more professional
 

JoCam

Trusted Information Resource
#10
Thank you pkost,

I've made the decision to over-label the manufacturer name but not change the device name. The manufacturer will be aware of what we are doing, so some kind of distributor agreement will be set up. It also transpires that we will be buying the product to rent out and not sell.

Thank you again,

Jo
 
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