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CE marking

« CE marking » was introduced pursuant to European technical harmonisation legislation.

It 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. To be entitled to affix "CE" marking to their products, manufacturers must conduct, or have conducted, controls and tests ensuring that the products comply 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.

Being both mandatory and regulatory, it represents a manufacturer's visible confirmation that its product complies with European legislation.

Products concerned

Whether a product manufactured in France or imported is subject to a "CE" marking obligation can be verified in the technical harmonisation directives or by referring to national measures transposing them.

These directives specify 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.

"New approach" directives providing for "CE" MARKING

Products Effective directive
Low voltage equipment 2014/35/EU
Simple pressure vessels 2014/29/EU
Safety of toys 2009/48/EC
Construction products (Regulation) 305/2011/EU
Electromagnetic compatibility (EMC) 2014/30/EU
Machinery 2006/42/EC
Personal protective equipment (PPE) 89/686/EEC
Medical devices 93/42/EEC
Active implantable medical devices 90/385/EEC
In vitro diagnostic medical devices 98/79/EC
Appliances burning gaseous fuels 2009/142/EC
Efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels 92/42/EEC
Explosives for civil uses 2014/28/EU
Medical devices 93/42/EEC
Equipment and protective systems intended for use in potentially explosive atmospheres (ATEX) 2014/34/EU
Recreational craft 2013/53/EU
Lifts 2014/33/EU
Pressure equipment 2014/68/EU
Measuring instruments 2014/32/EU

Radio equipment

Radio equipment and telecommunications terminal equipment

2014/53/EU

1999/5/EC

Cableway installations designed to carry persons 2000/9/EC
Non-automatic weighing instruments 2014/31/EU
Pyrotechnic articles 2013/29/EU
Restriction of the use of certain hazardous substances in electrical and electronic equipment(RoHS 2) 2011/65/EU

Conformity assessment

Product conformity assessment is usually carried out in two stages (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.

If an industrial product is 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.

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.

To verify 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".

 

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