OBL (Own Brand Labeling) - Full Quality to Production Quality

sriramsl

Involved In Discussions
#1
Dear Experts
Need advise again.
Currently we have CE marking for a Medical Device procured from a OEM under OBL route with a product model name 'XXX'. This is obtained under Full Quality Assurance - Annexure II. (Here the complete TF of the OEM is submitted from Design to manufacture - we only issue Labels and IFU with our Model name XXX)
Now we want to do 'manufacturing' of the same product with an agreement with the OEM that they supply us all the components. The final product will be exactly same as product 'XXX' in every aspect. We do not want to change the Model name of the product.
The questions are:
1. Do we have to build the TF again and get fresh CE marking approval by NB or
2. Do we have to mention only as significant change of 'manufacture' moved from OEM to our factory
3. Under which Annexure do we have to apply - Annex II Full Quality or Annex V - Production Quality?
 
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sriramsl

Involved In Discussions
#3
Re: OBL - Full Quality to Production Quality

Thanks Remus for the quick reply.

How come the answer can be Yes for both the questions 1 and 2. If I can file Significant change of Manufacture, then I dont have to prepare the full TF again and submit isn't it. Only documents related to the manufacture should suffice. Am I right?

Regards
Sriram
 

Remus

Involved In Discussions
#4
You have to prepare full technical documentation, however you can use your OEM's documentation. After that you need to manufacuture some products, prepare your process validations, quality and manufacuturing documentations. Then, your notified body will audit your manufacturing area, and documentation.

In my opinion prepare everything to your survalliance audit, dont pay extra audit fee.

PS: Talk with your notified body, because every NB have different aproach somehow.
 

Ronen E

Problem Solver
Moderator
#5
I second the recommendation to talk with the current NB because the current situation with OBL certification (in general) is unclear at best. The EU is generally moving away from what used to be referred to as OBL CE marking (certification of the OBL based on the OEM clearance).

My guess is that they will instruct you to prepare everything fresh and then get certified in your own right. The fact that your design and components will come from a certified manufacturer (the OEM) can help but it won't be a huge shortcut like OBL arrangements used to. You will most likely need the support of the OEM in terms of existing documentation.

The annex you need to apply is a function of device classification. Annex II is a catch-all route but it might be an overkill in your case (or not, depends on the class).

Good luck,
Ronen.
 

sreenu927

Quite Involved in Discussions
#6
I agree to Ronen that EU is moving away from OBL. Recently our Notified Body told "No" to OBL. Either you need to take the legal responsibility or act as a distributor.

Regards,
Sreenu
 
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