CE marking was set up according to European technical harmonisation laws
CE marking is mandatory for all products covered by one or more European directives which expressly provide for it and it guarantees free movement throughout the EU for these products. In order to be authorized to mention CE marking to their products, manufacturers must carry out controls and tests ensuring that the products do match with essential requirements, particularly those concerning health and safety, as set forth in the relevant directives.
CE marking is not certification and it does not attest to the product’s geographical origin.
As mandatory and regulatory, CE MARKING represents a manufacturer’s visible confirmation that its product complies with European legislation.
Scope of Products
In order to determine if a product manufactured in France or imported is subject to a CE marking obligation, it has to be verified according to the technical harmonisation directives or by referring to national measures transposing them.
Such EU directives are designed to define precisely
the scope of application for the relevant products and, where applicable, the excluded products. There are currently around twenty technical harmonisation directives providing for the affixing of CE marking relating to a huge range of products. Only the products mentioned in these directives are obliged to have CE marking.
Product conformity assessment is usually carried out in two steps (during design and during production).
There are eight assessment procedures (or modules) according to the product:
- internal production control;
- CE type examination;
- conformity to type;
- production quality assurance;
- product quality assurance;
- product verification;
- unit verification;
- full quality assurance.
The corresponding legislation specifies which modules apply to a given product.
CE conformity marking
- has the single graphic symbol CE and, if a notified body is involved in the product production control phase, the identification number of the relevant body;
- is affixed to the product, packaging or accompanying documents;
- enables the relevant product to be placed on the Internal Market and to move freely and be used there.
Should a product be covered by several directives providing for affixing of CE marking, the latter attests to compliance with all the directives in question. Other markings, particularly those concerning conformity with national or European standards may be affixed to products unless they may be confused with CE marking.
Certification of conformity
A product’s compliance with the essential safety requirements set forth in the corresponding technical harmonisation legislation has to be certified, usually by means of a declaration and a technical file.
CE declaration of conformity
The manufacturer or its authorised representative based in a European Economic Area Member State must establish a CE declaration of conformity even when it uses a third party control body.
In this document, the manufacturer certifies that its product complies with the essential regulatory health and safety requirements concerning it. It may be held liable in respect of the representations made in this document.
The details usually provided are:
- the name and address of the manufacturer or its authorised representative;
- a description of the product;
- reference to the harmonised standards or other technical specifications used;
- the signatory’s identity.
Where applicable, the certificate issued by the notified body used is enclosed with this document.
The technical file
In addition to this declaration, conformity assessment procedures usually require the manufacturer to establish a technical file to certify as to the product’s compliance. The technical file contains administrative information on the company and documents establishing the product’s compliance with technical rules (records, a description of the product and processes, drawings, etc.).
Only market surveillance authorities have the right to see the file and it does not have to accompany the product or be systematically presented.
Consequences of CE marking
Products subject to a directive providing for CE marking may not be placed on the market without this marking.
Once it has CE marking, the product may circulate freely on the Internal Market.
In order to check the marking’s validity, national product safety surveillance authorities (customs officers or the Directorate General for Competition Policy, Consumer Affairs and Fraud Control (DGCCRF)) may ask to see the declaration of conformity and the technical file.
Administrative and criminal proceedings may be instituted in the event of a lack of marking or fake marking.