Re: CE documentation

[Kees de Bondt <cbon -at- WXS -dot- NL>]

On 30-06-1998 21:53 Rebecca Siegel wrote:


>The company I work for develops hardware and software. We're just now
>moving into the international market with our newest hardware product
>(we're located in the U.S.) and need to have CE approval. The product
>developers tell me we can't get CE approval without the proper
>documentation. They gave me the official requirements document, which
>lists a lot of requirements but shows no examples.
>
>Since this is new to me, I'd really like to see a sample of how someone
>else has done this. Can anyone tell me how to tackle this, or does
>anyone have a sample set of CE doc pages they can send me?
>

For CE type A, in general there is nothing new you need for CE approval.
All the documentation you need will exist already in your R&D department
and quality system (if present): specs, tech-drawings, CM, etc. The only
difference is you have to organize it into a traceable filing system.

An important part of the CE documentation will be the user's manual. But
that's not new to tech-writers...

Another essential is the Manufacturer's declaration on conformity (e.g.
Directive 89/392/EG, IIA for machinery) in which the manufacturer
declares that his apparatus conforms EG-directives and a listed set of
norms and specs; dated and approved by your technical director.
For CE type B (e.g. medical apparatus) you need a notified body for
approval.

Regards,
Kees de Bondt



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