The role of harmonised standards in complying with relevant essential requirements identified by a manufacturer - a generic philosophy for cases where a manufacturer needs to identify relevant essential requirements
Where harmonised standards fail to indicate clearly the essential requirements aimed to be covered such standards may become less useful for manufacturers and market surveillance authorities as there is less legal certainty on the real ‘scope of presumption of conformity’. An unclear or incorrect indication of the essential requirements aimed to be covered may also lead, in some cases, to formal objections against harmonised standards (see point 4.1.2.5). Where a harmonised standard covers only part of the essential requirements identified as relevant by manufacturers or only certain aspects thereof, they additionally have to use other relevant technical specifications or develop solutions in accordance with general engineering or scientific knowledge laid down in engineering and scientific literature in order to meet the essential requirements of the legislation in question. In a similar way when manufacturers choose not to apply all the provisions given in a harmonised standard, and which normally would provide presumption of conformity, they need, on the basis of their own risk assessment, to indicate in their technical documentation how the compliance is reached or that relevant essential requirements are not relevant for the product. Occasionally standards may contain errors or offer different possible readings. If manufacturers find such an error or uncertainty, they should first make contact with the national standardisation body to seek for clarification.
Source: EUR-Lex (Cellar) · retrieved 2026-09-25 · Text as adopted (Official Journal); later amendments are not incorporated in this text.