posted 10 October 2000 01:17 PM               

I was involved a few years ago with the EMC, electromagnetic compatability directive for the company I was working with. I also got the pleasure of reading the Low Voltage Directive. We would not be allowed to sell in the EU after the directives were enacted without meeting the specs. However, we were able to self-declare.

ISO is also apparently required to sell in the EU now, but registration cannot be self-declared, and it does not call out product specifications as the CE Mark directives do.

Hope this clears some of the confusion up.

posted 10 October 2000 01:29 PM               

Per the Medical Device Directive, Class 1 non-sterile/non-measuring devices can be 'self-declared' (see Annex VII)and the CE mark applied without witnessed testing or quality system registration. You do need to have documented testing, technical files, etc. available upon request.

For Class 2a or higher, you need both a Declaration of Conformity and either registration to a recognized quality system (read ISO 9000) or witnessed (and expensive) testing.

This is a narrowly focused response to a very big question and all I can offer based on experience.

This is an area where a good consultant would be worth their weight in platinum!

Best of luck with this one.