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CE Regulations

All key requirements of directives relating to technical harmonisation.

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.

Act
Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonisation Directives. [Official Journal L 220 of 30.8.1993].

Summary
This Decision aims to protect public interests such as the health and safety of product users. Conformity

Conformity
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 to 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 CE 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 new product.
The CE marking can be introduced in Community legislation as a 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.

Assessment modules
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)

Context
Decision 93/465/EEC is repealed by Decision No 768/2008/EC on a common framework for the marketing of products. The provisions relating to EC marking are now contained in Regulation No. 765/2008.

Additional information from external websites
EU Law and Publications