Summary

Application field

The Decision 93/465/EEC states how affixing the CE conformity marking for the design, manufacturing, placing on the market or putting into service of a product.

The CE marking is adopted by the European legislation only when:

• A Directive following the principles of New Approach and Global Approach is applied;
• The method of global harmonization is used;
• The applied Directive contains procedures for the conformity assessment in compliance with the Decision 93/465/EEC.

Not all European Directives, therefore, allow affixing the CE marking, but only the one that follow the principles above. The products compliant with Directives not allowing the CE marking can move free on the European market, but they have to be accompanied by a declaration or a conformity certificate.

Manufacturer Responsibility

The CE marking shall be affixed by the Manufacturer or by his authorised representative in the Community. The Manufacturer assumes the total full responsibility of the product conformity.

The conformity assessment depends upon the phase if design or fabrication of the product. Depending on the adopted conformity assessment procedure, a Notified Body can take an action to one or both phases. When a Notified Body participate in production control phase, the marking is followed by the Notified Body identification number.

It is compulsory affixing the CE marking on those products which a Directive requiring the CE marking applies to.

Assessment modules

The Decision 93/465/EEC considers eight assessment procedures or modules applied to the phases of design and production:

• Internal control production (module A);
• EC 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).

Validity status

The Decision 93/465/EEC repealed and superseded by the Decision no. 768/2008/EC regarding a common framework for the marketing of products. The provisions regarding the CE marking are presently provided by the Regulation No. 765/2008.

Aspects related to the new approach and the global approach

a)      Council Resolution of 10/11/2003 on the Communication of the European Commission: “Enhancing the Implementation of the New Approach Directives” (Office Journal C 282 of 25.11.2003).

b)     Communication from The Commission o the Council and the European Parliament, 7.5.2003: “Enhancing the implementation of the New Approach Directives” [COM(203) 240 final] – not published in The Office Journal.

c)      Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998, “Laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services” (OJ L 204, 21/07/1998): this Directive is aimed at removing or limiting all barriers to free movement of products that can be a consequence of the adoption of different national technical standards.

d)      Council Resolution of 21 December 1989 on a global approach to conformity assessment (OJ No C 10, 176/01/1990).

e)     Council Resolution of 7 May 1985 on a new approach to technical harmonization and standards (OJ C 136, 4.6.1985).

Products safety

• Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (OJ L 11/4 of 15.01.2002): The general safety of products placed on the market is ensured by the Community legislation that guarantees a uniform and high level of protection of health and safety of the consumers.
• Council Regulation (EEC) No. 339/93 of 8 February 1993 on checks for conformity with the rules on product safety in the case of products imported from third countries (OJ L 040 of 17/02/1993).
• Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218/30 of 13.8.2008).