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Old 13th June 2018, 09:24 AM

Total Posts: 33
Re: Own brand labelling/virtual manufacture of IVD's

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?

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