Procedure for CE marking

Procedure for CE marking

Introduction

To ensure that products sold in EFTA countries (which consist of the EU plus Iceland, Liechtenstein, Norway, and Switzerland) and Turkey are suitable for being placed on the market, the EU sets out safety, health and environmental protection requirements. CE marking on a product indicates that the product meets these essential requirements and is therefore absolutely indispensable, not only for products manufactured in Europe but also for those marketed in the EFTA area, provided that these products are regulated in a Community Directive.
CE marking, therefore, guarantees that a product meets the requirements necessary to be sold and enjoy free circulation in the European market. It is the CE marking that demonstrates that the product can be sold in the EFTA area.
Obtaining the CE marking is the responsibility of the manufacturer or its authorized legal representative. In order for a product to bear the CE marking, the manufacturer of the product must declare, under its sole responsibility, the product’s conformity with all the requirements laid down in the applicable Community Directives.

  • Verification of applicable directives and compliance with essential requirements

As not all products are regulated by Community Directives that oblige them to be marked, the first step for a manufacturer should take is to check which Community Directives apply to its particular product.

If several different directives apply to a product, then the product must comply with all applicable directives.

 

Once the applicable directives have been identified, the manufacturer must ensure that its product complies with the essential requirements described. One way to do this is to apply the (voluntary) harmonized standards that are applicable to the product. The manufacturer is free to check the requirements using these standards. However, if the manufacturer does not wish to do this or there are no standards applicable to the particular product, they must ensure compliance by applying other standards or documenting the tests that have been carried out to ensure conformity.

  • Verification of conformity

Each directive sets out one or several methods (modules) for checking compliance with that directive.

Some of these modules require a self-declaration by the manufacturer, others require the intervention of a Notified Body such as Alter Technology and, in some cases, a combination of the two is required. Having a Notified Body involved in the process supports the proper functioning of products through specific testing to ensure the quality of products through specific product testing to ensure product quality. Depending on the case, either a type approval of the design or a total quality system may be required, according to the ISO 9000 series of standards.

  • Documentation: Technical Construction File (TCF) and Declaration of Conformity.

The Technical Construction File (TCF) gathers product information, test reports performed on the product to ensure conformity, and documentation demonstrating that the manufacturing process does not introduce variations in the product that could lead to non-conformities.

Finally, the Declaration of Conformity is the document by which the manufacturer declares that the product conforms to the applicable directives resulting from the preparation of the technical file.

  • CE marking on a productProcedimiento para el Marcado CE

The EU stipulates a minimum degree of visibility and proportion when incorporating the CE marking on a product. The following image demonstrates the seal’s required dimensions. The figure is in unspecified “units” because the EU specifies the proportions that must be maintained, not an absolute size. However, the EU does stipulate a minimum vertical size of 5 mm.

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