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Old 13th June 2018, 09:42 AM
nickie

 
 
Total Posts: 13
Re: Own brand labelling/virtual manufacture of IVD's

Thank you for your reply, sorry if I did not make it clear. Company A buys self test CE marked devices from manufacturer B. They assemble these devices with other components into kits which they sell under their (Company A's) own brand name, but place the OEM's details beside the manufacturer symbol on the packaging and state "distributed by" and their (company A@s) name and contact details.

My company assembles IVD tests under contract from OEM's but not own label. We are looking to purchase company A but if this would entail CE marking their products if they are not legally on the market this would obviously entail significant cost to us. I guess my main question is does declaring the OEM as manufacturer on the packaging and naming themselves as distributor remove their responsibilities to CE mark the kit, even if it is sold under their (the assembler's) brand name?

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