Further Own Brand Label questions - Urgent

peterDH

Starting to get Involved
#1
Dear Cove,
I posted on here a few weeks ago regarding an issue we are having on the issue of own brand lable agreements. To explain the issue we have a company assembling componets - one being a lancet. This lancet is CE marked by the manufacturer. In the last post i was asking regarding the OBL with the manufacturer. The issue we are having is due to the volume of these goods we purchase which is low, the manufacturer will not sign a direct agreement with us as we don't purchase the lancets directly but through the assemble compnay, we have even tried to buy them direct but the numbers that we purchase buy this company is "not sufficent". Now the lancets we purchase are CE marked for bulk purchase and we piggy back our CE mark due to the manufacturing having CE certification for this product.
Getting to the point the assembly company now has a distribution aggrement in place with the lancet manufacturer for which I have seen and it covers all aspects of the OBL you would wish for. My question is then if an agreement was in place between the distributor rather than the manufacturer and ourselves would this suffice?
Our Audiors disagree, however in most cases you do not directly talk to the manufacturere of goods but a distributor.

Can anybody help

Thank you

Peter
 
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somashekar

Staff member
Super Moderator
#2
Hi Peter...
1. Is your device also the 'Lancet' packed differently and placed in the market, than the one you purchase from the distributor ?
2. Is the Lancet that you purchase CE marked with a notified body number along with the CE ?

If 1. above is answered 'No' then there is no question about OBL.
When you say your auditors disagree, do you mean the Notified body ?

I am sure there is no OBL process without the original legal manufacturer's consent and the general OBL agreement with the original legal manufacturer. Distributor is only in the supply chain process and is a business call, and not a regulatory link for your process.
 

peterDH

Starting to get Involved
#3
Hello Somashekar,
The lancet is purchased as a bulk item and then repacked as a single item.
The lancet is CE marked and funniliy enough the assembliers use the same notified body as we do.

You are correct in this case i mentioned the auditors when i should have specifed the NB.

Dam, i was hoping that the distributor would suffice. The issue we have is that the lancet manufacturer does not want to enter into an OBL with us on volume. They see no need to from there point, but without this we are unable to CE mark the product. I know people will say go to another supplier, but that is a doomsday synario only.
Thank you for your imformation

Peter
 

somashekar

Staff member
Super Moderator
#4
I can understand you. If the lancet manufacturer sees his business grow more with your association, then signing the OBL agreement may be a part of the business strategy. As your volumes are less going by your own words, he is not keen, but you are keen for the OBL.
Regulatory costs money. This is simple truth.
Why not ask the lancet manufacturer for a one time cost that he is willing to take from you to get into the OBL agreement ?
Once this is done, with the same NB for both of you, your process of OBL CE will be that much more smoother.
Good luck.
 

peterDH

Starting to get Involved
#5
Dear Cove,
having looking at previous posts the issue we are having is to do with not being able to get an OBL in place with the lancet manufacturer due to volume ( too low). We need a CE marked product and then place into our own packaging which we then CE mark. If we placed the orginal manufacturers details on the pouch would this be a game changer?

sorry taken from a previous post (Pkost was the information supplier)
"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."

Would this cut mustard, or is an OBl the only way.
Sorry to sound like a broken record, but the lancet supplier does not wnat to enter into an agreement due to volume.

Any help or advise would be greatly appreaciated.

Peter
 

somashekar

Staff member
Super Moderator
#6
Hi there Peter.
This works. Only that the legal manufacturer has to again agree to have an other brand and part number label made and affix on the product, which will have him as the manufacturer and his product Ref number, and the CE mark with NB number (or agree that you will do this labeling) and this new label will get into his technical file as an other product label style, and he will be meeting all the applicable regulatory requirements on them.
Like the icecream is his, the cup is your's and the cup says the icecream manufacturer's name and variety, along with your brand and variety.
 
Last edited:

peterDH

Starting to get Involved
#7
Thank you Somashekar for your incite,
I hoping that because the details of the lancet were detailed on the outside of the pacakging this would suffice for the CE marking. In reality to enable piggy backing on CE certification for a product (which is CE marked but as bulk and not for single use) as soon as the lancet is taken from the bulk supplied product it looses CE certification. By putting the companies details on the packaging pouch i was hoping we would be able to maintain the CE traceability. I am trying any way to get around the OBL route as the manufacturer of the lancets will not sign one with us.
Thank you

Peter
 
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