F.A.Q. - Frequently Asked Questions

What is the CE Marking?

The CE marking is the Manufacturer's declaration demonstrating the compliance of the device with applicable European Directives. For most products sold in the European Community, the use of CE marking and the Declaration of Conformity is mandatory. With the exception of certain product categories expressly indicated in the Directives, the manufacturer may self-declare compliance with the essential requirements prescribed in the Directive by affixing the CE marking. The CE marking is an acronym that must be affixed visibly and indelibly on each product to attest that it meets the essential requirements set by one or more European Directives. The CE abbreviation, in the term CE marking, stands for "Conformité Européenne," literally translated as "European Conformity".

The CE marking allows products access to the European Market, but it is not an approval mark, nor a Certification or Quality mark, nor can it be used as a marketing tool.

The CE marking only declares that the manufacturer or distributor assumes responsibility for the product, allowing its free circulation in Europe. The CE marking should not be confused with other approval marks or certifications issued by Certification bodies.

As stated in the "European Commission Guide to the Implementation of Harmonized European Directives":

"Manufacturers are responsible for ensuring that the products they place on the market comply with the relevant regulations. Where these regulations do not require mandatory Certification, manufacturers often voluntarily seek Certification to ensure that their products meet the requirements imposed by law."

The Achievement Process

The process for achieving the marking depends on the Directive; however, in general, it requires:

  • Identification of all Directives applicable to the product
  • Analysis of essential protection and safety requirements
  • Analysis of risks associated with product use
  • Identification of applicable harmonized standards for the product
  • Performance of tests, measurements, or checks prescribed by harmonized technical standards
  • Preparation of the Technical File and its maintenance


The main purposes of the CE marking are:

  • Indicating product compliance with applicable directives and thus essential safety requirements
  • Allowing product access to the market
  • Ensuring free movement of goods
  • Allowing the withdrawal of non-compliant products by competent authorities or customs


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