2. Technical documentation
The manufacturer shall establish the technical documentation and make it available to the notified body referred to in point 4. The documentation shall make it possible to assess the machinery or related product’s conformity with the relevant essential health and safety requirements set out in Annex III, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable essential health and safety requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the machinery or related product. The technical documentation shall, wherever applicable, contain at least the following elements: the name and address of the manufacturer and, if the application is lodged by an authorised representative, the name and address of that authorised representative; the technical documentation for the unit of machinery or related products intended to be manufactured. In addition, the technical documentation shall, wherever applicable, contain at least: the elements set out in points (a) to (g) of Annex IV, Part A; the documentation concerning the quality system; and a written declaration that the same application has not been lodged with any other notified body.
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Source: EUR-Lex CELLAR · retrieved 2026-08-26 · Text as adopted (Official Journal); later amendments are not incorporated in this text.