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  • The CE Marking is required to sell any product manufactured or distributed under European Union (EU) New Approach Directives in the European Economic Area (EEA). The EEA consists of the 15-nation EU and the four-nation European Free Trade Association (EFTA).
  • The New Approach Directives, designed to eliminate technical barriers to trade in Europe, set product safety technical requirements. The most important of these apply to medical devices. Other directives include low voltage, simple pressure vessels, toys, construction products, electromagnetic compatibility, machinery, personal protection equipment, telecom terminal equipment, boilers, explosives and recreational craft.
  • The CE Marking is affixed to products after they are successfully tested for conformity to applicable directives.
  • For more information, see:

http://www.ce-marking.org/

 

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