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

["Gene Kim-Eng" <techwr -at- genek -dot- com>]

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.

^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^

Create HTML or Microsoft Word content and convert to Help file formats or 
printed documentation. Features include support for Windows Vista & 2007 
Microsoft Office, team authoring, plus more.
http://www.DocToHelp.com/TechwrlList

True single source, conditional content, PDF export, modular help.
Help & Manual is the most powerful authoring tool for technical
documentation. Boost your productivity! http://www.helpandmanual.com

---
You are currently subscribed to TECHWR-L as archive -at- web -dot- techwr-l -dot- com -dot- 

To unsubscribe send a blank email to 
techwr-l-unsubscribe -at- lists -dot- techwr-l -dot- com
or visit http://lists.techwr-l.com/mailman/options/techwr-l/archive%40web.techwr-l.com


To subscribe, send a blank email to techwr-l-join -at- lists -dot- techwr-l -dot- com

Send administrative questions to admin -at- techwr-l -dot- com -dot-  Visit
http://www.techwr-l.com/ for more resources and info.