WHAT IS CE MARKING? HOW TO GE CE CERTIFICATE?
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.
|Low Voltage Directive
|2009/105/EC, (ex. 87/404/EEC)
|Simple Pressure Vessels
|Ecodesign for Energy-related Products
|Noise Emission for Outdoor Equipment
|2009/48/EC 88/378/EEC, 93/68/EEC
|305/2011/EU (ex.89/106/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
|Hot-water Boilers (liquid or gaseous fuels)
|Explosives for Civil Uses
|Active Implantable Medical Devices
|In Vitro Diagnostic Medical Devices
|Equipment Explosive Atmospheres
|Radio Equipment and Telecommunications Terminal Equipment
|Cableway Installations to Carry Persons
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.