Own Brand Labeling Issues

peterDH

Starting to get Involved
#1
Dear all,
We have a current issue concerning own brand labeling and suppliers. We have a company that assembles a class IIa medical device product for us using componets sourced from multiple companies i.e these componets are CE marked as bulk items but not when single packaged. Due us being the registered manufacturer from the point of CE marking we hold all technical files etc on all the items used. The issue is our notified bodies is asking us to have the assembler become the "manufacturer" of the class IIa product. As the assembler is not the manufacturer of the item they quite rightly do not want to comply with this wish. Has anybody else encounterd issues when they have items repacked by an assembler company and ensured all rules can be complied with.? I am sorry if this not enough detail, but i can provide more.
Thank you

Peter
 
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peterDH

Starting to get Involved
#3
The item is a kit it contains items for blood collection i.e. lancet, wipe etc. Issues were that we could not have OBL's with the orgainal manufactures of some of the items because we were not the purchaser of the item. However the assembler does have a technical agreement in place that has satisfied the notified body.
 

somashekar

Staff member
Super Moderator
#4
Dear all,
We have a current issue concerning own brand labeling and suppliers. We have a company that assembles a class IIa product for us using componets sourced from multiple companies i.e these componets are CE marked as bulk items but not when single packaged. Due us being the registered manufacturer from the point of CE marking we hold all technical files etc on all the items used. The issue is our notified bodies is asking us to have the assembler become the "manufacturer" of the class IIa product. As the assembler is not the manufacturer of the item they quite rightly do not want to comply with this wish. Has anybody else encounterd issues when they have items repacked by an assembler company and ensured all rules can be complied with.? I am sorry if this not enough detail, but i can provide more.
Thank you

Peter
Hi Peter, Welcome here to the Cove.
I do not see an own brand label issue here. The assembler is your contract manufacturer and for the NB you are the legal manufacturer. This company that assembles for you has to follow your technical file requirements that has been reviewed and approved by the NB. As a part of the CE certification, the NB can seek to audit your assembling company periodically, and you must have agreements with that company to be acceptable to the auditing and to adhear to your approved technical file for the assembly which perhaps includes use of specific components within the bill of materials.
The NB may have a finding in the audit which can be well addressed but cannot demand that you make the contract manufacturer the legal manufacturer by he getting the CE and you then becoming the OBL manufacturer with a CE that depends on the other company maintaining the CE. Perhaps the NB is looking at more business opportunities than providing you a practical solution.
 

pkost

Trusted Information Resource
#5
I agree with somashekar, I don't understand why the NB is suggesting the assembler become the manufacturer if you hold the technical documentation and are CE marking it yourself.

I'd clarify exactly why they want the assembler to become the manufacturer, ask where it is a requirement, then tell them to stop being so stupid.
 
M

MIREGMGR

#6
Is the NB for some reason treating this as a regular assembled product rather than as a convenience kit?

Is there something odd about the way you've labeled the kit in the past, that causes the NB to be confused?
 

peterDH

Starting to get Involved
#7
Thank you all for your help, being thrown at the deep end to this I belived that the NB was beign daft. But until i felt that I was not going mad I did not want to confront them on this issue.
Thank you Peter
 

Ronen E

Problem Solver
Staff member
Moderator
#8
Thank you all for your help, being thrown at the deep end to this I belived that the NB was beign daft. But until i felt that I was not going mad I did not want to confront them on this issue.
Thank you Peter
Hi & welcome to the cove :bigwave:

Probably you have something in writing from your NB relating to this requirement / request ("if it's not written, it never existed"), so if you don't mind copying the relevant text here (just the core phrase, no need for the whole background) it could help clarify your situation and maybe allow more effective comment.

In general I tend to agree with the previous responses you got.

Cheers,
Ronen.
 

peterDH

Starting to get Involved
#9
Hello all,
I have posted the quote with names removed from the NB
My company need to get agreement with the product assembler who must have an OBL agreement with the OEM manufacture of the lancet. The product assembler would need to be certified as the manufacturer.
Now to expand the assembler has an agreement with the lancet manufacturer, this is to ensure if required sterility certs etc can be requested rapidly. I do however find the idea of an OBL stange as the all concerned have quaility system in place. Which would mean we all have vigilance procedures in place, if a failure of event were to occur it is our duty uinder our QC system to ensure other parties are ware of this issue. It seems the OBl is really the cherry on the cake as far as I am concerned. Evene the NB has agreed with me the the OBL really does cuase issues sometimes.

Once again that thank you
Peter
 

pkost

Trusted Information Resource
#10
An OBL agreement is only needed if the original manufacturer holds the technical file and you rely on their CE mark to apply your own. The agreement basically ensures that they maintain their CE mark and inform you of any changes. It also allows your NB/CA to review their technical documentation without you seeing it and ensures that the necessary vigilance is in place.

As you hold your own technical documentation you are not relying on their CE mark. You define the specifications and the original manufacturer acts in the role of sub contractor.


To be sure of your position you need to check the following:

- The kit that you assemble contains only CE marked devices. (this falls under article 11 and requires no agreements to be in place)
- where you modify CE marked devices that you have CE marked them yourself
- when you CE mark the devices yourself that you have ALL of the technical documentation and that you control it. This includes the device validation and all of that. By control it, I mean that the specification can only be changed on your authority.
- it is not acceptable to refer to the OEM's technical file in any way - this would require and OBL agreement.

If you have all of this in place then everyone is considered your subcontractor. It is irrelevent what CE marks are otherwise in place.

By way of examples:

Non OBL:
we have one product which is manufactured by our subcontractor. the design is to an ISO standard. We hold the technical file. they additionally manufacture the same products and stick their own name and CE mark on them...they hold their own technical file. If they were to change the specification of their product they would continue to make ours to our own spec. If they were to let their CE mark lapse ours would remain and we could still make ours. We could also decide to move to another sub contractor if necessary.

OBL in place:
another product that we sell we hold only a limited amount of technical information, in fact we are not entirely sure how the product is manufactured. We can only declare that the product meets the essential requirements because it is already CE marked by the original manufacturer. If they lose their CE mark we can no longer assume compliance with the ER's and therefore lose our CE mark.
 
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