When is a device "Own Brand Labelled"?

[DangerousDave]

I am clear on the fact that if a company (Company A) rebrands another companies device (Company B), they become the "legal" manufacturer and in the case of medical devices, notified body involvment is needed to obtain a Own Brand Label (OBL) certificate (along with all the bits that go with it).

So, if Company B sell thier device in thier own country of the EU, and Company A want to sell the device in the rest of the EU, what I am not clear on is whether OBL rules apply in either of the following situations:

1. A device is sold by Company A in Company B's original colours but Company B's branding is removed from the main label. Company B's manufacturer's name etc still appear on the device label on the back.
2. As above, but sold in Company A's colours. Still no branding and Company B's manufacturer's name etc still appear on the device label on the back.

In both of the above situations, my gut feeling is that this is still Own Brand Labelling as the device labelling is being modified from that which Company B would normally supply to the customer's in thier own country.

I appreciate other peoples opinions on this . . . . .

 

[pkost]

As long as the original manufacturer is identified on the label then it isn't OBL. It is required that it is obvious who the original manufacturer is, but there is no strict guidelines. For instance I have seen packaging where it is branded by one company but only a small corner identifies the "legal" manufacturer. Although it shouldn't, in reality it depends on how strict the original manufacturers NB is as to how much you can get away with.


For it to be a true OBL, the "distributor" is identified as the manufacturer, the "distributor" holds a CE mark and the "original manufacturer" is not identifiable anywhere on the label

 

[chudsy]

As long as the original manufacturer is identified on the label then it isn't OBL. It is required that it is obvious who the original manufacturer is, but there is no strict guidelines. For instance I have seen packaging where it is branded by one company but only a small corner identifies the "legal" manufacturer. Although it shouldn't, in reality it depends on how strict the original manufacturers NB is as to how much you can get away with.


For it to be a true OBL, the "distributor" is identified as the manufacturer, the "distributor" holds a CE mark and the "original manufacturer" is not identifiable anywhere on the label

pkhost,
Do you know where I can find any firm guidelines for your above comments (apart from bulletin no. 19!)
Many Thanks

 

[pkost]

Hi Chudsy,

Unfortunately the MHRA bulletin is the only guideline I'm aware of - other CA's may have similar guidelines but I'm UK based and don't speak any other languages so am not really in a position to check.

 

[chudsy]

Hi Pkhost,
I think you mentioned in a previous OBL thread that it does depend on how critical the NB is. We have a device which has the OEM's trademark all over it and their name on the label and packaging BUT it's our name on the manual and on the device label as well so I guess it's up to the NB!!!!
Thanks

 

[pkost]

To give you a bit of background....As a manufacturer we own label some of our products....there is no trace of the original manufacturer on the device. We also act as a distributor for other products and it is in this role that I have seen other (more dubious) methods. As I think I mentioned in the other thread I have seen one product where it took me a considerable amount of time to identify the "legal" manufacturer and realise that in truth they were different from the company that was selling us the product!

If this was legit (and we can only assume it was because we saw the CE certificate, the mark, CoC etc; and we have no authority to do anything more) then the NB must..(sorry read that as... "if they were doing their job properly should") have been aware of how it was labeled.

When we went through our OBL exercise I asked our NB about this case, the unofficial response was effectively that some places allow a smaller distributor mark, some allow an equal distributor mark and a few allow a smaller manufacturers mark. This was followed up with "All notified bodies and competent authorities apply the regulations equally....but....." and "we do it the right way"

To make sure you are doing it correctly, or at least appropriately, then you may want to speak to the legal manufacturer and get them to confirm the NB is aware of extent of the labeling. If you are the legal manufacturer, make sure your NB is aware of the labeling!

 

[chudsy]

Many thanks for your help, I just wish that there was something in black & white on this as sometimes the NB's can have a field day with 'their' opinions (blinkered at times!!)
Regards

 

[J0anne]

I hope this helps.

 

[krishna007]

still not clear..

What if we take this scennario, that we buy, store etc a device from a OEM (who already has a
CE mark and uses our trade name), but we want to be legal manufacturer (using our company name as manufacturer).
we go for conformity assessment and get it CE marked and list the product with the competent authority.
But we also consider that the OEM also continue our trade name (for some time). anyway the technical documentation is
not going to change any bit, indeed it is the OEM's documentation.

This means that the same product, with same brand/trade name is placed with 2 different manufacturer's name on the market.
Is this possible? if so what criterions and or critical points shall we keep in check.

I checked
- NB-MED/2.5.5/Rec 5 - Conformity Assessment of Own Brand Labelling
- MHRA bulletin 19
- MDD

The definitions for OBL does not clearly address the situation, or have i missed something.

thanks for your advice!

 

[somashekar]

It is possible as it is your business. However it is best to discuss this with the same NB who notify both you and the OEM. As long as the products have different Ref or Article number they are different products for regulatory. A product cannot be notified by two NB., However in your case they are not the same products.