Manufacturing sites of Class 1 Medical Devices



Hi all,

If I am buying a product from a non medical device manufacturer and then affix my CE mark on it (complete with a technical file, and DoC), can I then list my address as the manufacturing site? (if I don't want to disclose to the customer who my manufacturer is)


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you would not be the manufacturing site, but you could be the manufacturer as defined by the directive - the definition of manufacturer is specific and not necessarily tied to the location where the product is made.

The directive only requires the manufacturer be stated on pack so this is legitimate way to obscure your supplier
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