sec_4_1_1__para__3

Essential requirements must be applied as a function of the hazard inherent to a given product. Therefore, manufacturers have to carry out a risk analysis to first identify all possible risks that the product may pose and determine the essential requirements relevant for the product. This analysis implies that the manufacturer should assess all the different elements of the products and determine which Union harmonisation legislation applies to it, and which specific essential requirements as set out therein. This analysis has to be documented and included in the technical documentation (178). In addition, the manufacturer needs to document the assessment of how the risks identified are addressed to ensure that the product complies with the relevant essential requirements (for example, by applying harmonised standards). If only part of the harmonised standard is applied or it does not cover all relevant essential requirements, then the way relevant essential requirements not covered by it are dealt with, should be documented (179).

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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.