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Old 13th June 2018, 06:58 AM

Total Posts: 13
Please Help! Own brand labelling/virtual manufacture of IVD's

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.

Last edited by nickie; 13th June 2018 at 07:21 AM.

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