ANNEX VIII

The technical documentation shall make it possible to assess the conformity of the subsystem or the safety component with the applicable requirements of this Regulation and shall include an adequate analysis and assessment of the risks. The technical documentation shall specify the applicable requirements and cover, as far as relevant for the conformity assessment, the design, manufacture and operation of the subsystem or safety component. The technical documentation shall contain, at least the following elements: a general description of the subsystem or the safety component; design and manufacturing drawings and diagrams of components, subassemblies, circuits, etc. and the descriptions and explanations necessary for the understanding of those drawings and diagrams and of the operation of the subsystem or safety component; a list of the harmonised standards referred to in Article 17, applied in full or in part, the references of which have been published in the Official Journal of the European Union, and where those harmonised standards have not been applied descriptions of the solutions adopted to meet the essential requirements of this Regulation including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied; the supporting evidence for the adequacy of the design, including the results of any design calculations, examinations or tests carried out by or for the manufacturer and the related reports; a copy of the instructions for the subsystem or the safety component; for subsystems, copies of the EU declarations of conformity for the safety components incorporated into the subsystem.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-05 · Text as adopted (Official Journal); later amendments are not incorporated in this text.