nickie

Starting to get Involved
#1
Hello,
I would like some clarification please on what constitutes being " the manufacturer" of a self test IVD under the EU regulations. My company is currently negotiating the purchase of another small company (A) who assemble self test IVD's and distribute them under their own brand name but naming the OEM (B) on the packaging as the manufacturer and the packaging has the words "distributed by" (A) on it. Company A has ISO 13485. My belief is that company A is "the manufacturer" of these products and should hold the CE mark as they are assembling and selling them as their own brand but they argue that as the OEM is clearly stated on the box as the manufacturer and they just put "distributed by" them then they are not liable for the CE marking. It is my belief that the CE mark purely applies to the IVD device, not the test kit itself. They say audits of their ISO13485 system have not flagged up concerns about this.Because of confidentially issues I cannot at present approach the OEM for clarification. I would really appreciate advice please. Thank you.

PS I appear to have somehow posted this under the China regulations forum by mistake but am not sure how to correct this error and post under the EU regulations heading, sorry.
 
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BhupinderSinghPawa

Involved In Discussions
#2
The post is a bit confusing.

One interpretation of your post is that OEM (B) is the legal manufacturer responsible for CE mark, and the original label reflecting that. The Company (A), without covering or changing the existing label, adds its own address and contact details to the device or packaging - is the distributor. Also, the original label itself can mention Manufactured By and Distributed By.

If however, the Company (A) is assembles or repackages or relabels, then it is the legal manufacturer.

What business is your company in - manufacturing or distribution?
 

nickie

Starting to get Involved
#3
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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