What is CE Certification?
CE means European Conformity. It is a certification mark affixed on the product which indicates health, safety and environmental protection standards of products sold within the European Economic Area (EEA). This mark is also found on products sold outside the EEA that are manufactured in, or designed to be sold in the EEA. The CE marking is declaration of manufacturer’s which says that it fulfills the requirements of the applicable EC directives. Once the applicant gets the CE marking, he will have to provide all the supporting documents of CE marking to distributors or importers. CE marking is mandatory for certain product groups which are located within the European Economic Area. The manufacturer and the importer of goods must ensure that the EC marked goods conform to the standards.
How to Obtain CE Marking?
- Know the EU requirement for your product
- Check the specific requirements of your product
- Check whether your product requires testing by a national body
- Test your product
- Compile with the technical requirement
- Affix the CE marking and draft a declaration of conformity
Types of CE Marking
Depending on the level of risk of the product, CE marking is affixed to a product by the manufacturer or authorized representative who decides whether the products meet all the CE requirements.
- Minimal Risks: If the product has minimal risk than a self-declaration along with the Declaration of conformity will be required from the manufacturer for affixing CE marking to their product.
- Greater Risks: As per the directives the products which have greater risks should independently get their product certified by a notified body. It is a body which is notified by the European Commission. It serves as an independent test lab and performs the functions as directed by the EU directives. The notified body must have the necessary qualifications to meet the requirements set forth in the directives. The body can be a private organization or a government agency.
Procedure to Affix the Mark
Responsibility of CE marking lies with the EU manufacturer, importer or distributor of a product made outside EU who want to sell the product in the EU market. The manufacturer of a product affix the CE marking to it but certain prerequisite conditions before the product bear CE marking. The manufacturing should carry out assessment and prepare a technical file and sign the declaration as prescribed under the law.
Certain point’s to be kept in mind before affixing the marking are:
- CE marking and certain EU directives must be followed before placing the product in the market.
- It is the responsibility of the manufacturers to check, which EU directives will apply to their products.
- The product may be placed on the market only if it complies with the provisions of all applicable directives and regulations and if the conformity assessment procedure has been carried out accordingly.
- The manufacturer signs an EU declaration of conformity EU standards and then affixes the CE marking on the product.
- If there is any requirement in the directives or regulations, a Notified Body is authorized to carry out the assessment procedure or in setting up a production quality system.
- The CE marking affixed on the product must be clearly legible and visible for easy identification.