While manufacturers can self-certify many products under the New Approach Directives, certain high-risk products cannot be self-certified. These higher risk products require the services of a "notified body" within the European Economic Area (EEA). The EEA consists of the EU plus the European Free Trade Association countries of Iceland, Norway, and Liechtenstein, excluding Switzerland.
Notified bodies are independent testing houses or laboratories authorized by the EU member states to perform the conformity assessment tasks specified in the directives. A notified body may use a subcontractor to perform part(s) of a conformity assessment procedure. Many U.S. testing houses act as subcontractors to the EU notified bodies. However, the notified body is the ultimate authority, and a company must gain notified body approval in order to claim CE marking compliance for its project. For information on how to obtain a list of notified bodies, look at http://ec.europa.eu/enterprise/newapproach/nando. For a list of U.S. companies that subcontract to EU notified bodies, go to “Testing/Certifying Labs” on this website.