CE Marking Process

CE Marking Process

Introduction

To ensure that the products sold in the EFTA countries (made up of the EU plus Iceland, Liechtenstein, Norway and Switzerland) and Turkey are suitable for commercialization, the EU establishes requirements for safety, health and protection of the environment. The CE Marking on a product indicates that it meets these essential requirements. This marking is therefore absolutely indispensable not only for products manufactured in Europe but for those that are marketed in the EFTA field, provided that these products are regulated in a community directive.

The CE Marking indicates therefore that a product meets the necessary requirements to be marketed and have free circulation in the European market. In this way, thanks to the CE marking, the product has the possibility of being sold in the EFTA space.

The CE Marking is the sole responsibility of the manufacturer or its authorized legal representative. In order for a product to have the CE mark, the manufacturer of the product has declared, under its exclusive responsibility, compliance with all the requirements stipulated in the applicable EU directives.

  • Verification of applicable directives and compliance with essential requirements

As not all products are regulated by community directives that force them to be marked, the first step for a manufacturer would be to check which community directives would apply to your specific product.

If a product is subject to several directives, it is required that it complies with all applicable.

 

Once the applicable directives have been determined, the manufacturer must ensure that his product meets the essential requirements. One way to do this is to apply the harmonized (voluntary) standards that apply to your product. The manufacturer is free to check the requirements using these standards, but if he does not do so or there is no application to his specific product, he must ensure compliance by applying other standards or documenting the checks he does to ensure compliance.

  • Verification of conformity

Each directive establishes one or several methods (modules) to check compliance with this directive.

Some of these modules require a self-declaration by the manufacturer, intervention by a Notified Body such as Alter Technology or, in some cases, a combination of the two. The importance of the notified bodies in the process supports the proper functioning of the products through specific tests on the products that guarantee the quality of this. Also in some cases a type approval of the design or a total quality system is required according to the ISO 9000 series of standards.

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

The Technical Construction File (ETC) collects product information, test reports made on it to ensure compliance and documentation that demonstrates that the manufacturing process does not introduce variations in the product that may cause non-conformities.

Finally, the Declaration of Conformity is the document by which the manufacturer declares that the product is in compliance with the application directives resulting from the preparation of the technical file.

  • CE marking on the productProcedimiento para el Marcado CE

Incorporation of the CE seal on the product with the minimum visibility and proportion of the EU. The following image marks the dimensions that the seal must have. The figure is in “units” without specifying because the EU forces to keep the proportions, not the total size. Although it puts a minimum vertical dimension of 5mm.

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