The CE mark  is a figure that a manufacturer   affixes to a product so that it can be put in market of  European Union. The CE mark is mandatory for products which fall under one of twenty four  European directives. The CE mark means that the manufacturer takes responsibility and fulfill the requirement of the standart and directives  for their products. CE means for “Conformité Européenne”, the French for European conformity.

The mark is required in all 27 member states of the EU, as well as Iceland, Norway, Liechtenstein and Turkey.   

Definition of manufacturer in CE Marking:
The  legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under its own name.

CE is not like other certification marks.
The Canadian Standards Association (CSA) or the Underwriters’ Laboratories (UL) marks, for example, can only be used when those organizations have determined that a product meets applicable standards and directive.European organizations do not grant authorization to use the CE mark as it is not owned by any particular notified body. The manufacturer is whole responsible for its proper use.

The manufacturer, whether established inside or outside the EU, is all responsible for affixing the CE mark and is also responsible for its proper useage. The manufacturer established outside the EU may assign an authorized representative established in the EU to process on his behalf. CE marking is about more than affixing a symbol to a product.

Find the CE directive(s) that applies to your product.

How do you know if your product requires a proper CE mark? The first step is to define if your product is covered under one or more of the 24 CE directives following. If your product falls under any of these directives, it needs to be CE marked.

Directive NumberProduct Category
2014/35/EU(ex.2006/95/EC)Low Voltage Directive
2009/105/EC, (ex. 87/404/EEC)Simple Pressure Vessels
2009/125/ECEcodesign for Energy-related Products
2000/14/ECNoise Emission for Outdoor Equipment
2009/48/EC 88/378/EEC, 93/68/EECToy Safety
305/2011/EU (ex.89/106/EEC )Construction Products
2014/30/EU(ex.2004/108/EC)Electromagnetic Compatibility
2006/42/ECMachinery Safety
2016/425/EC(ex.89/686/EEC )Personal Protective Equipment
2009/23/EC (ex. 90/384/EEC)Non-automatic Weighing Instruments
2009/142/EC (ex 90/396/EEC)Appliances Burning Gaseous Fuels
92/42/EECHot-water Boilers (liquid or gaseous fuels)
93/15/EECExplosives for Civil Uses
2017/745/EU(ex.93/42/EEC)Medical Devices
2007/47/ECMedical Devices
90/385/EECActive Implantable Medical Devices
98/79/ECIn Vitro Diagnostic Medical Devices
94/9/ECEquipment Explosive Atmospheres
94/25/EC, 2003/44/ECRecreational Craft
97/23/ECPressure Equipment
2014/53/EU(ex.99/5/EC)Radio Equipment and Telecommunications Terminal Equipment
2000/9/ECCableway Installations to Carry Persons
2004/22/ECMeasuring Instruments
2007/23/ECPyrotechnic Articles

Declaration of Conformity  and  affixing the CE mark

The document certifying compliance with CE marking directives is the Declaration of Conformity. The Declaration of Conformity is an acknowledgement by the producer that they are responsible for the conformity of its products with the applicable directives.

This document is the manufacturer’s whole responsibility, and the establishment of the Declaration of Conformity is a legal obligation.

The declaration should be available to authorities at the EU point of entry. Contrary to the complete technical documentation , the Declaration of Conformity must be made available to EU distributors, who may be required to provide it to national authorities immediately upon request.

The Declaration of Conformity is generally  a one-page that includes the following:

  • who you are,
  • what product it refers to,
  • what directives are involved,
  • which standards have been used,
  • where test results can be found,
  • who is responsible in your company.

Assessment of conformity by an NB ( CE Certification):

The manufacturer is required to use an NB to check conformity and certify its products, but it ultimately remains responsible for their conformity with EU essential requirements.
Conformity assessment to the European directives for CE marking may consist of different directives, including product testing, visual inspection, risk analysis , inspections and a review of product labels and instructions. Typical steps which may be involved in the assessment of conformity include:

  • Review of the technical documentation related to the design, manufacture and/or operations of the product;
  • Testing of one or more specific aspects of each product, or of a sample of the products, or of a representative specimen of the product;
  • Assessment of the production quality systems of the manufacturer; and
  • Ongoing verification of product unit conformity.
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