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In the European Union conformity assessment procedures have been developed for each "New Approach" Directive. Manufacturers have the option of choosing which conformity assessment procedure they wish to pursue. Depending on the products and the health and safety risks they present, these conformity assessment choices can range from a full quality assurance system guided by special requirements (e.g. medical devices) to manufacturer self-certification (e.g. toys). Because there is a choice, the EU considers this process to be voluntary rather than mandatory; the manufacturer chooses the conformity assessment option. After choosing a conformity assessment procedure, manufacturers must satisfy the requirements of that choice (often called conformity assessment modules) before they are allowed to affix a CE Mark on their products. SIMCOM offers various services to accommodate whatever choice a company makes.

International trade is now recognized as the engine of global economic growth - largely thanks to the multilateral trading system. Over the 50-year lifespan of the WTO and its predecessor, the GATT, global trade has grown 17-fold, production has quadrupled and per capita income has doubled. Within this picture, the EU is the world largest trade partner, accounting for over a fifth of all exports in 1999 and, following completion of the "internal single market" in 1992, one of the world's most open markets. With 320 million citizens, it is now also the biggest single market in the world and will be bigger still in the next decade, after candidate countries from Central Europe and the Mediterranean have become members - extending the world-wide benefits of the open EU single market even further. The rule-based, open, multilateral, international trade system is a key factor in EU (and global) prosperity. The EU wants to see these advantages extended and therefore proposed a comprehensive new round of trade negotiations, which should entail concrete benefits for developing countries and contribute to better enhance benefits and limit risks arising from the globalization process, reflect the interests of society as a whole and bring real, visible benefits to everybody.


Click here to browse for standards associated with each specific European Union New Approach Directive.

Keywords: CE marking, CE Mark, European business, EU regulations, EU business requirements, European trade barriers, New Approach directive, technical construction file, EN, prEN, ISO, IEC, ITU, ETSI, CEN, CENELEC, EU regulatory compliance