CE Marking 1.CE Marking on a product is a manufacturer’s declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation, in practice by many of the so-called Product Directives.* *Product Directives contains the "essential requirements" and/or "performance levels" and "Harmonized Standards" to which the products must conform. Harmonized Standards are the technical specifications (European Standards or Harmonization Documents) which are established by several European standards agencies (CEN, CENELEC, etc). CEN stands for European Committee for Standardization. CENELEC stands for European Committee for Electrotechnical Standardization.
1.CE Marking on a product indicates to governmental officials that the product may be legally placed on the market in their country. 2.CE Marking on a product ensures the free movement of the product within the EFTA & European Union (EU) single market (total 28 countries), and 3.CE Marking on a product permits the withdrawal of the non-conforming products by customs and enforcement/vigilance authorities.
Along with more directives’ becoming effective, more and more products are required to bear the CE Marking for gaining access to the EFTA & European Union market. However, many non-EU exporters are still unaware of or unsure about this fact and its impact on their business. There are a series of steps outlined below. Depending upon your product and the nature of the risks it presents: 1.Determine if any directives apply to your product. If more than one applies you will have to comply with all of them. 2.Determine the extent to which your product complies with the essential requirements for design and manufacturing in the applicable directive(s). 3.Choose the conformity assessment procedure from the options (modules) called out by the directive for your product. There are several modules available for the Conformity Assessment Procedures as listed below: Module A: internal production control Module Aa: intervention of a Notified Body Module B: EC type-examination Module C: conformity to type Module D: production quality assurance Module E: product quality assurance Module F: product verification Module G: unit verification Module H: full quality assurance

The directives often use a series of questions about the nature of your product to classify the level of risk and refer to a chart called "Conformity Assessment Procedures". The chart includes all of the acceptable options available to a manufacturer to certify their product and affix the CE Marking. Minimal Risk Options for products with minimal risk include self certification where the manufacturer prepares a Declaration of Conformity and affixes the CE Marking to their own product. Greater Risks Many directives require products/systems with greater risks to be independently certified; this must be done by a "Notified Body" This is an organization that has been nominated by a Member Government and has been notified by the European Commission. Notified bodies serve as independent test labs and perform the steps called out by directives. They must have the necessary qualifications to meet the testing requirements set forth in the directives. Notified bodies may be a private sector organization or a government agency. Manufacturers may choose a notified body in any member state of the European Union. Lists of notified bodies are published by the European Commission in the Official Journal of the European Communities.
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