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TECHNICAL FILES – CE MARK

In a globalized environment as the current one, a need is raised to establish minimum requirements for the production and marketing of products whose safety is especially critical. For this purpose, the European Union has adopted a number of European Directives which establish standards for specific product categories and make mandatory the CE (CE Mark) in order to market their products in the European Economic Area, or the manufacturer is located inside or outside E.U.

What is CE mark?

This is a manufacturer’s declaration that the product complies with the European requirements for safety and health of consumers or the environment , as defined in the European Directives.

Some products requiring CE marking under European law are listed below:
  • Low Voltage Equipment.
  • Simple pressure vessels.
  • Games.
  • Construction Products.
  • Electromagnetic Compatibility.
  • Personal Protection Equipment.
  • instrumentation.
  • Medical equipment.
  • Gas appliances Fuel.
  • Hot water boilers with liquid or gaseous fuel.
  • Explosives for civil use.
  • Equipment and protective systems for explosive atmospheres.
  • Yachts.
  • Elevators.
  • Engines.
  • Diagnostic medical devices in vitro.
  • Radio and telecommunications terminal equipment.
  • Facilities for transporting persons moving with cables.
  • Eco-friendly design of products that consume energy.
  • Recognition of European Directives related to this product.
  • Recognition of the class is part of the product in accordance with the criteria set out in European Directives.
  • Testing of product samples . Depending on the type of product and the extent to which this may affect human life or the environment requires a different degree of validation and testing by the manufacturer or by external laboratories.
  • Writing technical documentation which substantiates the compliance of the manufacturer with the requirements of European Directives .
  • Depending on the type of product may require the inspection of the ” Notified Body” which will certify the adequacy of technical documentation and the correct application of Application to the “Competent Authority ” for inclusion in the register of manufacturers, after which the manufacturer has the right to mark the product with the CE Mark.
  • Periodic reassessment of the manufacturer to maintain the right to use the CE Mark.

Our company undertakes all the processes from the technical documentation of the product to the certification of this independent audit-testing certification and label compliance product.

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