The product scope in Union harmonisation legislation
Union harmonisation legislation applies to finished products, as defined by the scope of each specific Union harmonisation legislation. Yet, the concept of product varies between different pieces of Union harmonisation legislation. The objects covered by legislation are referred to, for instance, as products, equipment, apparatus, devices, appliances, instruments, materials, assemblies, components or safety components, units, fittings, accessories, systems or partly completed machinery. Thus, within the terms of a specific Union harmonisation act, components, spare parts or sub-assemblies may be regarded as finished products and their end-use may be the assembly or incorporation into a finished product. If this is the case, such products must comply with the applicable legislation at the time they are placed on the Union market (and/or put into service), that is, when they are first supplied for distribution, consumption or use on the Union market. When a finished product incorporating another product is placed on the Union market, the manufacturer is responsible for the compliance of the complete product with the applicable legislation. The manufacturer of this finished product can rely on the conformity assessment of the integrated product to build the Declaration of Conformity, conformity assessment and documentation of the product. Unless there are more specific provisions, Union harmonisation legislation applies to the products it defines within its scope, irrespective of whether they are being supplied ready for use or intended for installation. It is the responsibility of the manufacturer to verify whether or not the product is within the scope of a given piece of Union harmonisation legislation (36) (37). A combination of products and parts, which each comply with applicable legislation, does not always constitute a finished product that has to comply itself as a whole with a given Union harmonisation legislation. However, in some cases, a combination of different products and parts designed or put together by the same person is considered as one finished product which has to comply with the legislation as such. In particular, the manufacturer of the combination is responsible for selecting suitable products to make up the combination, for putting the combination together in such a way that it complies with the provisions of the laws concerned, and for fulfilling all the requirements of the legislation in relation to the assembly, the EU Declaration of Conformity and CE marking. The fact that components or parts are CE marked does not automatically guarantee that the finished product also complies. Manufacturers must choose components and parts in such a way that the finished product itself complies. The manufacturer must verify on a case-by-case basis whether a combination of products and parts has to be considered as one finished product in relation with the scope of the relevant legislation. If there are two or more finished products made available in the same package which do not constitute a single finished product but which are intended to function together, the manufacturer marketing the combination must address the risks of the products included in the package when used in operation with each other.
Source: EUR-Lex (Cellar) · retrieved 2026-09-25 · Text as adopted (Official Journal); later amendments are not incorporated in this text.