I only have direct experience with the regulatory situation
I described, i.e., CE and FDA on the same product.
This is why I told Sylvia to consult the specific regulation
applicable to her situation.
Gene Kim-Eng
----- Original Message -----
From: "Jonathan West" <jwest -at- mvps -dot- org>
> For the CE mark, the form of the declaration depends entirely on which
> particular regulation you claim conformity with. There are quite a few
> regulations which don't require any particular form of declaration,
> since placing the product on the market and applying the CE mark is in
> itself a declaration of conformity with the relevant EU regulations.
> If you want to be sure you have it right, there is no alternative but
> to read the relevant regulations and find out what they require.
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