RE: It's not just a good idea; it's the law

Subject: RE: It's not just a good idea; it's the law
From: "Dan Goldstein" <DGoldstein -at- riverainmedical -dot- com>
To: <techwr-l -at- lists -dot- techwr-l -dot- com>
Date: Wed, 16 Jan 2008 10:45:43 -0500

This might be true as a general rule, but note the following from
"Council Directive 93/42/EEC Concerning Medical Devices":

"Member States may require the information, which must be made available
to the user and the patient in accordance with Annex I, point 13, to be
in their national language(s) or in another Community language, when a
device reaches the final user, regardless of whether it is for
professional or other use."

It's still up to the member state's discretion, but the cost of
translation won't necessarily get you a waiver.

> -----Original Message-----
> From: Gene Kim-Eng
> Sent: Wednesday, January 16, 2008 10:35 AM
> To: Techwr-l
> Subject: Re: It's not just a good idea; it's the law
>
> The EU document requirements contain specific exceptions
> for products that have no domestic equivalents. IOW, if
> you manufacture something that nobody else can provide
> with the required translations and you decide not to
> translate because the market doesn't justify the
> expense, faced with the prospect of not being able to
> obtain any product, the requirement will be waived and
> your products will be allowed in without CE marking...
>

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Follow-Ups:

References:
Re: It's not just a good idea; it's the law: From: Liz Goodwin
Re: It's not just a good idea; it's the law: From: Gene Kim-Eng

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