Ed, according to my senior design professor (whom works at Ension) and those whome work at another small medical device company here in Pittsburgh. It's far easier to get a CE mark in Europe to begin selling products then moving out to other countries/continents (where the CE covers most of your paperwork).
After you've made a good amount of money, you then try for FDA approval. If you (as a small company) try to get through the FDA first, you risk bankrupting yourself.
That is interesting (and supports my point). I can imagine it on a smaller scale -- between states within the US instead of between countries. If I wanted to create something requiring permits from each state, I would not want to start in Chicago or Detroit (where I would have to curry favor with Big Gov't power-broker crony henchmen mobsters). All big, burgeoning governments attract people with bad manners (i.e., corrupt people). Think about it on an even smaller scale. Let's say there is a national park with an actual tank from WWII on it. People may try to use the tank for the purpose of destruction, but it would only be bad people who would be attracted to that kind of destructive power asymmetry.
The letters "CE" are the abbreviation of French phrase "Conformité Européene" which literally means "European Conformity". The term initially used was "EC Mark" and it was officially replaced by "CE Marking" in the Directive 93/68/EEC in 1993. "CE Marking" is now used in all EU official documents.
[an error occurred while processing this directive]