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To: Kevmo

Does this CE certification require the device to work?

http://en.wikipedia.org/wiki/CE_mark

A snippet of the article:
Legally, the CE marking is no quality mark. But depending on the applicable directive the CE marking factually can be considered to be a quality mark. Deviating from sectoral directives regulating other industrial goods, medical devices have to comply with “essential requirements” as described in Annex I of Directive 93/42/EEC, according to which medical devices have to be not only safe but also function in a medical-technical way as described in the manufacturer’s “intended purpose”. Compliance with these requirements is proved within a certified quality management system according to EN ISO 13485.

It seems if it’s a medical device it does have to do what it says. I don’t see that for other devices although I could be wrong and if I am, I’m sure someone will point it out.


6 posted on 10/24/2011 7:48:27 PM PDT by Lx (Do you like it, do you like it. Scott? I call it Mr. and Mrs. Tennerman chili.)
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To: Lx
Does this CE certification require the device to work?

As you indicate, some devices have to function according to your documentation. But even that doesn't mean that they work. For example, an EEG machine may blink lights and show some graphs on the screen, but it doesn't mean that it produces any useful output. The standard is only concerned with using it during the test as a customer would.

Most of the compliance testing is done based on honesty of everyone involved. For example, if you are certifying a gadget you test what you are going to manufacture, and not a hand-built and hand-optimized version of it. The lab people wouldn't know the difference because they aren't going to travel to China to see what comes from the production line. A less than honest manufacturer can always test a product that is built well enough, and then manufacture a cheaper version of it. In essence, as long as he is not sued nobody would ever know what he did.

15 posted on 10/24/2011 10:43:43 PM PDT by Greysard
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