What is the procedure for CE-marking?

New Approach Directives broadly describe the essential requirements that products must meet. The manufacturer may indicate themselves as to how they will comply to the essential standards and directives. Often European (harmonized) standards (EN standards) are used to in the process . These standards give precisely the technical requirements that a product must meet. The application of harmonized standards, leads to presumption of conformity with the essential requirements of the applicable Directive (s). The CE-marking symbolizes conformity to all requirements for the product according to the essential requirements out of the New Approach directives. The application of the mark rests with the responsible party. In addition to affixing the CE-marking, the responsible party must comply with the following administrative requirements:

  • EC Declaration of Conformity
The EC Declaration of Conformity is a document which the manufacturer(or his agent) or importer declares that the product conforms with the essential requirements of the relevant New Approach Directive (s). The declaration contains the following main elements:
    • Company name and complete address of the manufacturer and, where appropriate, his agent
    • Product identification (name, function, model, type, serial number and trade name and any relevant additional information)
    • The directives concerned and where appropriate harmonized standards or other technical standards and specifications
    • When appropriate the name and address of the person who is responsible to compile the technical file in the Community,
    • When appropriate name, address and identification number of the notified body
    • Identity and signature of the person authorized to act on behalf of the manufacturer or his representative to compile the declaration
    • The date on which the declaration is issued
    •  Technical File
The Technical File (TF) contains relevant information that must indicate that the essential requirements out of the applicable directive (s) have been met. The TF must be available for the competent authorities of the Member States for at least 10 tears after the date of construction of the machine or, in the series production, the last unit produced. For the manufacturer, his authorized representative or the importer, the TF also is used as technical evidence, that can offer possibilities of defense during a liability claim. The contents of the TF is must be in compliance and in accordance with the directives established for the products. In general a TF includes the following:
    • a general description of the product;
    • a risk assessment to identify health and safety requirements on the applicable product;
    • design and fabrication drawings;
    • detailed technical information on key aspects of the product;
    • a list of standards and essential requirements that are met;
    • reporting of calculations and tests;
    • certificates and test reports;
    • User Manual;

Users manual

The New Approach Directives have a direct relationship with the safety of the user. The information that is given to the user plays an essential role in accident prevention and reducing the risks regarding safety. The preparation and provision of the safety instructions governing the use is fundamental legal safety requirements. The manual should contain all information necessary for the proper and safe use of a product.
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