Who needs the CE Mark and CE certification? A primer for medical manufacturer

Europe is easier to access than ever before. Still, many North American device manufacturers exporters, especially small and medium sized enterprises, avoid it because the regulatory requirements for entry seem too complicated or expensive. North American manufacturers who have successfully accessed the European market know that taking the time to understand the European system is worth the effort. The European Union has a population of 490 million people, about the same as all of North America.
The European Union now includes 27 countries. Three additional countries (Iceland, Liechtenstein and Norway) are not EU members but are included in the European Economic Area (EEA). Switzerland is not part of the European Union.
For the exporter, Europe's regulatory requirements are easier to meet than even before. Before the creation of the European Union, each country imposed its own regulations. Different standards and regulatory procedures forced exporters to target one or two countries only, or to forego exporting to Europe altogether. The unification of 27 European countries into a European Union, and the resulting unification of laws, standards, and procedures, changed all that.