Depending on your product, you may need to wait several years before making your first mass shipment to Europe.
Any export from the United States to Europe must obtain a CE Mark from the European Union. A CE Mark indicates that a product has met all the legal and safety laws (known as directives) as specified by the EU. While these requirements may seem daunting at first glance, the CE Mark is the only way to access the EU consumer market on a mass scale. The application addressing laws, conformity and technical compliance must be sent to the EU Department of Commerce once complete.
Address all the Directives
Identify all EU directives that might pertain to your product. You will need to write a report explaining how your product is in compliance with each. For example, the EU has different electrical voltage requirements than the United States. The technical reports should detail the modifications you made to ensure proper compliance of the specific directive.
Show the Brainpower Behind Your Product
All manuals, studies and research should be included in a major technical file. This is an opportunity for the manufacturer to demonstrate the knowledge invested by both himself and any organizations who may have conducted consumer reports or academic studies involving the product.
A Declaration of Conformity
This is a document which states that you, the manufacturer, have conformed with each of the EU specified directives. Some products will allow you to "self-certify" through private research and development, but others such as medical devices and chemical processors, would require the certified approval of a third party such as the FDA or Chemical Safety Board.
Ongoing Monitoring
Explain how you will continue to monitor the safety and compliance of your product should it become available on the European market. Outline your distribution paths and vendors to demonstrate that you will be able to contact the appropriate party if a product needs to be modified or recalled. Finally, describe what steps are in place to ensure that any safety issues are reported promptly to the manufacturer.
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