sec_4_3__para__3

The contents of the technical documentation are laid down, in each Union harmonisation act, in accordance with the products concerned. As a rule, the documentation has to include a description of the product and of its intended use and cover the design, manufacture and operation of the product. The details included in the documentation depend on the nature of the product and on what is considered as necessary, from the technical point of view, for demonstrating the conformity of the product to the essential requirements of the relevant Union harmonisation legislation or, if the harmonised standards have been applied, to these by indicating the essential requirements covered by the standards. The requirements in Annex II of Decision No 768/2008/ EC refer to the contents of the technical documentation that are relevant for proving the conformity of the product with the applicable harmonisation legislation. Furthermore, the requirement for an ‘adequate analysis and assessment of the risk(s)’ requires the manufacturer to first identify all possible risks of the product and determine the specific Union harmonisation legislation and essential requirements applicable. This analysis has to be documented and included in the technical documentation. In addition, the manufacturer needs to document the assessment of how he is addressing the risks identified to ensure that the product complies with the applicable essential requirements (for example, by applying harmonised standards). If only part of the harmonised standard is applied or it does not cover all applicable essential requirements, then also the way applicable essential requirements not covered by it are dealt with should be documented in the technical documentation.

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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.