Declaration of Conformity (CE Marking)

Many products must have a CE marking before they may be placed on the market in the European Economic Area (EEA). The CE marking indicates that a product complies with European safety, health and environmental requirements.

As a manufacturer or importer, you are responsible for affixing the CE marking. You do this by means of an EU declaration of conformity in which you declare that the product complies with all relevant European legislation. CE marking is mandatory for various product groups such as toys, machinery, medical devices and electrical equipment.

Requirements

  • Applicability: Product falls under European product legislation requiring CE marking
  • Conformity assessment: Product must meet essential requirements from relevant directives and regulations
  • Technical file: Manufacturer must compile technical file with all evidence
  • EU declaration of conformity: Written declaration confirming conformity

Procedure

  • Identify legislation: Determine which European legislation applies to the product
  • Conformity assessment: Have product tested or test yourself for conformity with essential requirements
  • Notified body: For certain products, assessment by notified body is mandatory
  • Technical file: Compile technical file with all relevant information
  • Declaration of conformity: Draw up and sign EU declaration of conformity
  • CE marking: Affix CE marking on product and packaging

Restrictions

  • Manufacturer responsibility: CE marking may only be affixed by manufacturer or importer
  • Incorrect CE marking: False or unjustified affixing of CE marking is punishable
  • Market surveillance: Supervisors can inspect products and remove them from the market
  • Retention obligation: Technical file and declaration of conformity must be retained for 10 years