Re: CE means "Can't Enforce."

From: Joerg (notthisjoergsch_at_removethispacbell.net)
Date: 07/26/04


Date: Mon, 26 Jul 2004 20:40:48 GMT

Hi Paul,

> ... The EMC directive, I suspect, was only ever really intended to
> affect imports, but ended up giving a huge advantage to Europe's
> competitors- they can put their products on their own markets, and get
> revenue while they are testing for European compliance. We have to pay
> all the costs up front.

EMC should be one of the easier parts in getting a product to market.
After all, you have to comply in the US as well and the regs aren't much
different anymore these days. Seeing it from the American side and for
medical electronics I found it easier to start initial trials and first
customer shipments in Europe. Yes, EMC has to be done but that's just a
chunk of work. What often matters more are the regulatory burdens in
regards to the targeted use of a product, whether that be a car, a
medical device or an airplane. Here it is a matter of patience, not so
much a matter of how much work you put into it. You file, then all you
can do is wait. In our case it takes a long time to get through FDA and
less time to obtain a clearance for clinical trials in Europe. So, these
trials usually start over there. EMC is always squared away by then.

Regards, Joerg

http://www.analogconsultants.com



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