Own Brand Labelling and Distributors - Self Test IVD's

#1
Hi

I would appreciate some help with the following scenario.

We (UK Company B) purchase Self test IVD's for home use (pregnancy tests) from OEM (China Company A) as OBL with our name.

We have ISO 13485 and Notified body approval as an OBL.

We have a request from UK Company C (UK retailer) to provide them the same product with company C trademark on front of pack and company C pack design with Company C noted as distributor and company B as manufacturer.

Our notified body has said this can't be done. Notified body and all the regulations seem to say that Company C becomes the manufacturer and has to fulfill all the required manufacturers quality system requirements as well as apply to their own notified body for approval of the products.

Every UK retailer as well as many European retailers has their own brand of pregnancy test branded as their product but with distributed by instead of themselves as the manufacturer. It has been this way for many years.

How is this achieved or has it all changed with the adoption of the 2013 & 2016 rules?
 
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#2
It is possible for your brand to act as declared manufacturer on pack, while displaying another brand. As you said - many other companies do this.

You need to understand why your notified body has said no, perhaps they are misunderstanding your requirements.

key things required for this:
Technical agreement to identify obligations
IP agreement - license for you to use their brand and that they are the exclusive purchasor
 
W

wrodnigg

#4
From the viewpoint of the European Commission we should not certify OBL on OBL (and they do not like OBL at all)

So the solution is either a new OBL-certification directly in combination with the OEM, or a new brand name within the current OBL certification.

If you are still the declared manufacturer on the label and instructions for use, you can add the brand C to your certification.
Maybe you should redesign the label that there is a clear distinction between manufacturer (with the production plant symbol) and "distributed by company C". Just ask your NB.

.oO(I thought in GB any OBL would be easy cheesy)
 
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