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: "Gene Kim-Eng" <techwr -at- genek -dot- com>
To: "Dan Goldstein" <DGoldstein -at- riverainmedical -dot- com>, <techwr-l -at- lists -dot- techwr-l -dot- com>
Date: Wed, 16 Jan 2008 08:41:46 -0800

It's not your cost of translation that may result in a
waiver, but the decision you make, based on that
cost, to not sell the product in the member state,
and the demand from potential buyers in that state
who are faced with the prospect of not being able
to obtain your product or any equivalent one. If
there's someone else with an equivalent product
who is domestic to the member state or willing to
pay the costs of translation, you can forget about
a waiver.

Gene Kim-Eng


----- Original Message -----
From: "Dan Goldstein" <DGoldstein -at- riverainmedical -dot- com>
> 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.

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

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