CE conformity marking
Harmonised methods for assessing conformity with the technical harmonisation directives promote the placing on the market of industrial products and assist in the implementation of the internal market. Conformity assessment can be subdivided into modules that relate to the design phase of products and to their production phase.
This Decision establishes a range of procedures for assessing the conformity of industrial products to the "essential requirements" laid down by the technical harmonisation Directives. It aims to protect public interests such as the health and safety of product users.
The CE marking symbolizes the conformity of a product to the Community requirements incumbent on the manufacturer of the product. It indicates that the product conforms with all the Community provisions providing for its affixing.
Member States may not restrict the placing on the market and entry into service of products bearing the CE marking, unless there is supporting evidence of the product’s non-conformity. The marking should be affixed prior to the product being placed on the European market and entering into service.
The Decision lays down rules for affixing the CE conformity marking concerning the design, manufacture, placing on the market and entry into service of a product.
CE marking can be introduced in Community legislation as conformity marking if:
- a directive is in accordance with the principles of the new approach and the global approach;
- the method of total harmonisation is used;
- the directive contains conformity assessment procedures in accordance with this Decision.
Declaration of conformity
Directives may exclude the affixing of the CE marking on certain products. These products may circulate freely on the European market if they are accompanied by, for example, a declaration or certificate of conformity.
Responsibility of manufacturers
The CE marking must be affixed by the manufacturer or his agent established within the Community. The manufacturer bears ultimate responsibility for the conformity of the product.
Conformity assessment relates to the design and production phases of the product. Depending on the conformity assessment procedures applied, a notified body may be involved in these two phases. If the notified body is involved in the production control phase, its identification number will follow the CE marking.
If a product falls within the scope of a directive that provides for the CE marking, this should be affixed:
- to all new products, whether manufactured in the Member States or in third countries;
- to used and second hand products imported from third countries.
The decision provides for eight assessment procedures or "modules" which cover the design and production phases:
- internal production control (module A);
- CE type-examination (module B);
- conformity to type (module C);
- production quality assurance (module D);
- product quality assurance (module E);
- product verification (module F);
- unit verification (module G);
- full quality assurance (module H).
|Act||Entry into force||Deadline for transposition in the Member States||Official Journal|
|Decision 93/465/EEC [procedure COM/93/144-02]||22.07.1993||-||OJ L 220 of 30.08.1993|
Further information is available on the website of the European Commission’s Enterprise and IndustryDirectorate-General.
For a CE marked product to be approved, a manufacturer has to be able to prove that the product has passed the appropriate quality assurance tests. A manufacturer has to hire a qualified third party to perform these tests. Both the products and the manufacturing process need to be tested. If a manufacturer has dozens of products, this process can take a long time.
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