RE: Tech doc requirements for European markets

["Dan Goldstein" <DGoldstein -at- riverainmedical -dot- com>]

> -----Original Message-----
> From: Mike Sawyer
> Sent: Tuesday, January 12, 2010 5:12 PM
> To: techwr-l -at- lists -dot- techwr-l -dot- com
> Subject: Tech doc requirements for European markets
> 
> A client's client (long story) will be expanding sales into 
> several European countries, and they'd like to know well 
> ahead of time what requirements there are for localized 
> technical documentation. So this post isn't regarding the 
> translation, per se, but what are the "must-have" items for 
> European tech doc from a legal standpoint...

You're absolutely right -- your client's client is looking at *legal*
requirements. Keep track of all the friendly advice you get from us
Whirlers, but also remember who we are. Some of us have long experience
in preparing documentation for Notified Bodies and Authorized Reps, but
very few actually work for a Notified Body.

> ...More specific requirements may be specified in a product type CE
> "directive"...

Can you be more specific about your product type?

http://ec.europa.eu lists 29 separate directives. Each directive offers
a choice of dozens of Notified Bodies.

> ... There are no real standard warning formats/icons in 
> Europe (except maybe in Germany)...

How about ISO 3864, for starters?



















































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