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View Full Version : CE marking of products - How do you know if your product requires it?


ISO 13485 - Medical
31st March 2008, 07:15 PM
With regards to CE marking products for sale in the EU, how do you find out if your product requires to be CE marked?

Also if your product doesnt need to be CE marked can you display a CE mark on your product?

Many Thanks,

Gert Sorensen
1st April 2008, 03:07 AM
Whether your product needs to be CE-marked is a matter of whether there exist EU directives relating to your product. If - as your name implies - you produce medical devices then your products need to comply with the medical device directive and as such needs to be CE-marked. Other examples could be for instance electronic components or building materials.
:bigwave:

temujin
1st April 2008, 03:48 AM
Hi,

A list of European directives can be found here (http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist.html).

What kind of products are you wondering about?

The CE Mark is for showing conformity with one (or more) of these directives. If your product does not fall under the scope of any directive, a CE Mark does not really make sense.

t.

M Greenaway
1st April 2008, 04:03 AM
CE marking something for which there is no requirement is illegal.