The CE Mark, which is affixed to a product or its packaging, is considered proof that a product has met the requirements of the harmonized European standard, or directive; refers to Communauté Européen.
Translated from the French, this literally means European Community.
The European Commission, which administers the program, describes the CE Mark as a passport for goods to be sold freely within the internal European market. It is required by law if the product falls under one of the New Approach Directives. It is not a quality mark, nor is it a mark for consumers. Intended for Member State authorities, it is the visible sign to those authorities that your product is in compliance with the New Approach Directives. All manufacturers are required to affix the CE mark to products that are governed by New Approach Directives. CE marking on a product indicates to all authorities that the product is in compliance with the essential health and safety requirements of all directives that apply to the product.
The first step to compliance is determining which directives apply to the product. A product may be regulated by more than one directive. The CE mark does not disclose which directive(s) or standards apply to the product, nor will it indicate the method of conformity assessment used to bring the product into compliance. This information is provided by other accompanying documents, such as the Declaration of Conformity. The Manufacturer or the Authorized Representative affixes the CE marking to the product. It is not affixed by a Notified Body.
Process of CE Marking ( Self-certification Mode ) :
- Study which directive/s is applicable
- Determine which standard/s are applicable
- Test your product to ascertain if it complies
- Make a test report
- Make Technical Construction File:
Technical documentation - The manufacturer must draw up a Technical Construction File (TCF). The technical documentation is intended to provide information on the design, manufacture and operation of the product.
- Prepare a technical file documenting compliance with the applicable requirements.
- Prepare and sign a manufacturer’s self-declaration of conformity.
- Apply the CE Mark to the product.
- Ship the product to the European Union with a copy of the signed declaration of conformity, Instruction booklet for safe use and maintenance.
NOTE:
High risk products cannot be self certified.
Higher risk products will also call for implementation and certification of the designated Quality Management System.
You cannot CE Mark your product, if there are no applicable Directives for your product. General Product Safety Directive is not to be counted.
Process of CE Marking ( Third party-certification Mode )
The steps essentially remain the same.
In this case, the test must be witnessed by a Notified Body.
The test report will be made by the Testing Laboratory, and declaration will be made by the Notified Body.
The CE Mark will carry a number linking to the Notified Body.
