What is CE marking?

CE marking is a certification mark that must be legally affixed to products that must be in compliance with the essential requirements out of the European New Approach Directives. 'CE' stands for 'Conformité Européenne'. With the mark, the manufacturer, his authorized representative or the importer ( also for products imported from outside the European Union) indicate that the product meets the legal requirements described in the applicable directive (s). All products bearing the CE marking have free access to the entire market within the European Economic Area (EEA). Products that are not in compliance with the essential requirements out of the European Directives and further have no CE marking, can not be legally traded within the EEA.

Which countries belong to the European Economic Area (EEA)?

The following countries are part of the European Economic Area (EEA): • The Netherlands
• Bulgaria
• Romania
• Belgium
• Luxembourg
• France
• Germany
• Italy
• United Kingdom
• Ireland
• Denmark
• Greece
• Spain
• Portugal
• Austria
• Finland
• Sweden
• Cyprus
• Estonia
• Hungary
• Latvia
• Lithuania
• Malta
• Poland
• Slovenia
• Slovakia
• Czech Republic

Which products does the CE-marking apply to ?

Products that fall under at least one the New Approach Directives should be provided with CE-marking. The New Approach Directives are applicable for the following products:
• Active implantable medical devices
• Equipment in explosive environments
• Constructional products
• Pressure equipment
• Pressure vessels with a simple construction
• Electromagnetic products
• Explosives for civil use
• Gas appliances
• Electric material for low voltage
• Machinery
• Medical devices
• In vitro diagnostic medical devices
• Measuring equipment
• Non-automatic weighing instruments
• Public cableway installations
• Lifts
• Personal protective equipment
• Recreational craft
• Radio equipment and telecommunications terminal equipment
• Toys
• Efficiency requirements for oil and gas fired central boilers

Who applies the CE-marking?

This is different for each product. For a large number of products with a low safety risk, the manufacturer can determine whether it meets the essential requirements out of the related Directives as long as the procedures are correctly followed.

Products with a higher risk should be tested and verified by an external examination institution, also known as a Notified Body (Notified Body).

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

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;
• in series production , the internal rules that are adhered to
   ensure accordance with the Directive (s)

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.

What penalties exist for non-compliance with the CE marking?

If a product unlawfully is affixed with the CE marking the government has the power to take economic measures as well as criminal measures. Products can for example be withdrawn from the market and penalties can be imposed. Based on the law on economic crime the Prosecutor even impose imprisonment of manufacturers, importers or its authorized representative.