sec_4_1_3__para__2

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.

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Source: EUR-Lex (Cellar) · retrieved 2026-09-25 · Text as adopted (Official Journal); later amendments are not incorporated in this text.