§4.1.3 Conformity with the essential requirements: other possibilities

— The conformity of a product with essential or other legislative requirements may be demonstrated not only by harmonised standards referenced in the OJEU but also by other standards or technical specifications. — This is essential because not every harmonised standard has to cover all possible products and/or essential requirements. The application of harmonised standards is not the only means to demonstrate the conformity of a product. The manufacturers can choose whether or not to apply and refer to harmonised standards. However, if manufacturers choose not to apply harmonised standards, they have the obligation to demonstrate that their products are in conformity with essential requirements by the use of other means of their own choice that provide for the level of safety or protection of other interests required by the applicable legislation. These can be other standards such as national standards, international standards, European standards the references of which are not published in the OJEU, or other technical specifications such as European standardisation deliverables (200) (deliverables other than European standards developed by the ESOs), or the manufacturer’s own specifications. In these cases the manufacturers do not benefit from the presumption of conformity, but have to demonstrate the conformity themselves. This implies that they demonstrate, in the technical file of a relevant product, in a more detailed manner how the standards or technical specifications they use provide conformity with the essential requirements (201), for instance by carrying out a more in-depth risk assessment on the product, a gap analysis, etc. It is important to stress that Union harmonisation legislation for products does not, as a general rule, impose the use of harmonised standards. Only essential requirements are legally binding and manufacturers may apply whatever standards and technical specifications – however only harmonised standards which references are published in the OJEU provide a presumption of conformity. Some Union harmonisation legislation (202) which relies on harmonised standards provides for certain alternatives or complementary means to harmonised standards for demonstrating compliance of a product or a service. Some of these alternatives are mandatory (203) while others provide a presumption of conformity in a similar manner as harmonised standards (204). As a rule, these alternatives are foreseen as a fall-back option mainly for situations where harmonised standards do not exist (yet) and harmonised standards remain the preferred option.

← 4.1.2.5 · All articles · 4.2 →

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