§4.5.1.6 Which products must (not) be CE marked

— The CE marking must be affixed before any product subject to it, is placed on the market, save where specific Union harmonisation legislation requires otherwise. — Where products are subject to several Union harmonisation acts, which provide for the affixing of the CE marking, the marking indicates that the products are declared to conform to the provisions of all these acts. — A product may not be CE marked, unless it is covered by a Union harmonisation legislation providing for its affixing. Not all products have to be CE marked (239). The obligation to affix the CE marking extends to all products within the scope of legislative acts providing for its affixing, and which are intended for the Union market. Thus, the CE marking must be affixed: — to all newly manufactured products that are subject to legislation providing for CE marking, whether manufactured in the Member States or in third countries; — to used and second-hand products imported from third countries that are subject to legislation providing for CE marking; — to substantially modified products that, as new, are subject to legislation providing for CE marking and which have been modified in a way that could affect the safety or the compliance of the product with the applicable harmonisation legislation. In some cases, a product is deemed final for the purposes of a particular Union harmonisation act and has to be CE marked. This same product then is incorporated in another final product which is itself subject to another Union harmonisation act which also requires CE marking. This produces a situation where more than one CE marking can be found on a product (240). Union harmonisation legislation providing in general for CE marking may exclude the application of the CE marking on certain products. As a general rule, such products are subject to free circulation, if: a. They are accompanied by: — a Declaration of incorporation for partly completed machinery, according to the Machinery Directive; — a Declaration by the manufacturer or the importer in the case of partly completed watercraft referred to in the Directive on recreational craft and personal watercraft. b. They are accompanied by an attestation of conformity in the case of components as defined in the Directive on equipment and protective systems intended for use in potentially explosive atmospheres (ATEX). c. They are accompanied by a statement in the case of: — custom-made medical devices and devices intended for clinical investigations referred to in the legislation on medical devices; — devices intended for performance evaluation referred to in the legislation on in vitro diagnostic medical devices. d. They are accompanied by a certificate of conformity in the case of fittings referred to in the Directive relating to gas appliances. e. The product bears the manufacturer’s name and an indication of maximum capacity in the case of instruments not subject to conformity assessment according to the Directive relating to non-automatic weighing instruments. f. The product is manufactured in accordance with sound engineering practice in the case of certain vessels referred to in the Directives relating to simple pressure vessels and pressure equipment. In addition, the Directive on pressure equipment entitles Member States to authorise, on their territory, the placing on the market and the putting into service by users, of pressure equipment or assemblies not bearing the CE marking, but that have been subject to a conformity assessment carried out by a user inspectorate instead of a notified body.

← 4.5.1.5 · All articles · 4.5.1.7 →

Source: EUR-Lex (Cellar) · retrieved 2026-09-07