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Re: QUERY: Declaration of Conformity in User Documentation
Subject:Re: QUERY: Declaration of Conformity in User Documentation From:SB <sylvia -dot- braunstein -at- gmail -dot- com> To:"Gene Kim-Eng" <techwr -at- genek -dot- com> Date:Mon, 1 Sep 2008 18:04:03 +0300
Thanks to all for your feedback :-)
On 9/1/08, Gene Kim-Eng <techwr -at- genek -dot- com> wrote:
>
> 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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