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CE Marking Requirements

The CE Mark is a requirement for products sold to the European Market. The CE Mark identifies a product as complying with the health and safety requirements spelled out in European legislation (Directives) and is mandatory for equipment operating in the European Union (EU). Once the CE Mark is properly affixed on your product, it can circulate freely throughout the European Union countries.

Previously, companies that would export to Europe had to conform to various national laws. Now, the proper affixing of the CE Mark enables exporters to market to all European Union member states simply by conforming to the applicable European Directives and the use of European Standards.

Compliance is not a voluntary process. Affixing the CE Mark on a product exported to Europe is a legal requirement for the manufacturer. Compliance is enforced on a national level: Imports may be held at the port of entry, removed from the market, and heavy fines imposed on manufacturers if their product(s) fails to comply.

European Directives become effective at various dates and are subject to amendments. In addition several Directives can often apply to a same product/equipment.

Once the Conformity Assessment project is completed, the manufacturer is assured that its product/equipment is in compliance.

A typical Conformity Assessment program consists of the following:

  •  An understanding of the Directives/Standards that apply to your product/system
  •  A hazard analysis and safety review checklist
  •  Preparation of a Technical Construction File
  •  Testing as needed and third party reports
  •  The completion of the Declaration of Conformity
  •  The application of the CE Mark and other required markings

Directives

The European Union (EU) Directives are binding legislation addressed to its Member States. Legal requirements relate to various categories of goods and must be completely met before the manufacturer can legally affix the CE Mark on its product(s)/equipment. Enforcement is conducted on a national level of the member state.

European Directives become effective at various dates and are subject to amendments. In addition several Directives can often apply to the same product/equipment.

Examples of Directives

General Directives:

  • Product Safety (2001/95/EC)
  • Product Liability (85/374/EEC) Etc.

Product Specific Directives:

  • Machinery (2006/42/EC)
  • Low Voltage (2014/35/EU)
  • Electromagnetic Compatibility (2014/30/EU)
  • Personal Protective Equipment (89/686/EEC)
  • Medical Devices (93/42/EEC)
  • Simple Pressure Vessels (2014/29/EU)
  • Pressure Equipment (2014/68/EU)
  • Gas Appliances (2009/142/EC)

Standards

The EU Directives explain what must be done; The Standards explain how it can be done. A harmonized standard must match the essential requirements of the relevant Directive. A European standard may contain provisions relating not only to essential requirements but also to other provisions. In such a case, these provisions should be clearly distinguished from those covering the essential requirements. Furthermore, a harmonized standard does not necessarily cover all essential requirements. In such a case, it is up to the manufacturer to use other relevant technical specifications in order to meet all the essential requirements of the Directive.

Thousands of standards (in draft or harmonized version) exist. Safety Standards typically fall into three categories:

  • Type A Standards (Fundamental Safety Requirements)
    Basic concepts which can be applied to all product categories

  • Type B Standards (Group Safety Standards)
    Safety aspects used for a wide range of products

  • Type C Standards (Product Safety Standards)
    Detailed safety requirements for a particular product or group of products
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