Which products must receive the CE mark

• Rules for marking with the CE symbol

The CE marking symbolizes the conformity of the product with all obligations officially imposed on manufacturers under Community directives, which are required when placing this marking. If the marking is placed on the product, it constitutes a declaration that the natural or legal person, along with placing the marking, or taking responsibility for its placement on the product, agrees to all relevant legal regulations and that the product has been subjected to the appropriate conformity assessment procedures. Therefore, member states cannot restrict market access for products with the CE marking unless it can be proven that the product does not meet the conditions set for it. Directives requiring the placement of the CE marking stem mostly from the principles of the New and Global Approach, but this in itself is irrelevant to the application of the CE marking. In fact, the CE marking may be introduced into Community legislation as an official conformity marking when:

• the principle of total harmonization has been applied (this means the abolition of national regulations contradictory to the given directive);

• the directive contains a conformity assessment procedure in accordance with Council Decision 93/465/EEC.

Basically, all New Approach directives provide for the placement of the CE mark. In cases justified, a New Approach directive may replace the CE marking with another type of marking (e.g., directives concerning marine equipment do not require marking with the CE symbol).

Since all products to which the New Approach directives refer are marked with the CE mark, this marking is not intended for commercial purposes. The CE mark cannot be considered a mark of production origin, nor does it mean that a given product was made in the Community.

• Products subject to marking with the CE symbol

The obligation to affix the CE mark extends to all products that are covered by directives providing for the affixing of this mark and which are to be placed on the Community market. Therefore, the CE marking must be affixed:

• on all new products manufactured in member states or third countries;

• on used products imported from third countries;

• on significantly modified products, and thus subject to directives concerning new products.

 

Directives may exclude the affixing of the CE mark in cases of specific products, even when the directive otherwise refers to this product. Basically, such products benefit from the principle of the free movement of goods, if:

• they are accompanied by a declaration of conformity (i.e., elements intended to improve product safety, referred to in the machinery directive, as well as partly completed yachts to which the recreational craft directive refers);

• they are accompanied by a declaration of conformity (i.e., products of lesser importance to health and safety listed in accordance with the construction products directive);

• they are accompanied by a statement (as is the case in the case of custom-made medical devices and devices intended for clinical investigations, to which the directives on active implantable medical devices and medical devices and devices intended for performance evaluation, referred to in the directive on in vitro diagnostic devices refer);

• they are accompanied by a certificate of conformity (as is the case with components referred to in the directive concerning potentially explosive atmospheres, to be used in systems and protective equipment, and installations referred to in the gas appliances directive);

• the product bears the manufacturer’s name and an indication of maximum volume (as is the case with instruments not subject to conformity assessment in accordance with the provisions of the non-automatic weighing instruments directive); or

• the product is manufactured according to best engineering practice (as is the case with certain vessels referred to in directives concerning simple pressure vessels and pressure equipment).

During the transitional period, the manufacturer usually has a choice between complying with the requirements of the directive or the relevant national regulations. The chosen option should be explained by the manufacturer in the declaration of conformity of the European Community and in the documents, notes, or instructions attached to the given product.

• Marking with the CE
  symbol

The manufacturer, regardless of whether their registered office is located within the Community or outside it, is ultimately responsible for the conformity of the product with the provisions of the given directive and for affixing the CE mark to the product. The manufacturer may appoint a representative based within the Community to fulfill this obligation. In exceptional cases, it is recognized that the manufacturer’s obligations are assumed by the person responsible for placing the product on the market.

Basically, the CE marking cannot be affixed to the product if the conformity assessment procedure has not been completed and if the conformity of the product with all provisions of the relevant directives is not ensured (verified). Usually, the marking is affixed to the product in the final phase of production. It is not a problem to affix the CE symbol, e.g., on a rating plate that is attached to the product only after final inspection.

However, if the CE marking is permanently attached to the product or is part of it (e.g., as a result of stamping or embossing), this marking may be affixed to the product at any stage of production.

As a rule, the CE mark must be affixed to the product or its rating plate. Additionally, it may be affixed to packaging or accompanying documents. Only in exceptional situations can the CE marking be removed from the product or its rating plate. Removal is justified if affixing the mark to the product is impossible (e.g., on certain types of explosives) or is not possible from a technical or economic point of view, or when it is impossible to maintain the minimum dimensions of the marking, or it is not possible to ensure the placement of the mark in a visible place, legible and indelible. In such cases, the CE marking must be placed on the packaging (if any) and on the documents accompanying the given product (if the relevant directive provides for such documents). The CE marking cannot be omitted or transferred from the given product to its packaging or accompanying documents for purely aesthetic reasons. The regulations concerning the placement of the CE marking differ in some directives: e.g., in directives concerning simple pressure vessels or gas appliances they are stricter, and in others more flexible (e.g., directives concerning low-voltage equipment or toys).

The CE mark symbolizes conformity with the fundamental public interests covered by the relevant directive, therefore this mark is considered essential information both for member states and for third parties, e.g., distributors, consumers and other users. The visibility requirement for the CE marking states that it must be easily accessible to surveillance authorities. It may be placed on the back or bottom of the product. To ensure the marking is legible, its minimum height must be 5 mm. The durability requirement means that the CE mark cannot be removed from the product without leaving traces that would be visible under normal conditions (some product standards use water and white spirit abrasion tests). This does not mean, however, that the CE marking must be an integral part of the product.

Depending on the conformity assessment procedures applied, a notified body may be involved in the procedure (in the design phase, production phase, or both). When a notified body is involved in the production phase, the identification number of the notified body should be placed next to the CE mark. Therefore, the identification number of the notified body participating in the assessment of conformity in accordance with model B is never placed next to the CE mark. Several notified bodies may be involved in the production phase when more than one directive is applied. In this case, several identification numbers of the notified bodies are placed next to the CE marking. Therefore, the CE mark may appear on the product both:

• without an identification number; this means that the notified body did not intervene in the production phase [modules A, module Aa 1, module C bis 1 (if the notified body intervened only at the design stage) and the combination of modules B and C];

• with an identification number, which means that the notified body assumes responsibility for:

  • tests of individual product characteristics (modules Aa 1 and C bis 1,
    when the notified body intervened during the production phase),

  • product checks (modules Aa 2 and C bis 2),

  • examinations and tests carried out to assess product conformity during the production control phase (modules F, F bis and G),

  • assessment of production, product quality assurance or full quality assurance (modules D, E and H and their variants).

The process of affixing the CE marking and the identification number of the notified body does not necessarily have to take place within the Community territory. The CE marking and identification number may be affixed in a third country, e.g., if the product is manufactured there, and the notified body has carried out the declaration of conformity in accordance with the directive in that country. The CE marking and identification number may also be affixed at another time, provided they remain subsequently connected.

The CE marking consists solely of the letters “CE”, followed by the identification number of the notified body involved in the production phase. Pictograms or other signs indicating, for example, the use of the product are, according to some New Approach directives, complementary to the CE marking and do not form part of it (e.g., the symbol indicating that telecommunications terminal equipment is suitable for connection to the public telecommunications network).

• The CE mark and other
  markings

• they fulfill a different function than the CE mark;

• they are not confused with the CE mark;

• they do not restrict the legibility and visibility of the CE mark.