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anx_II__cpt_1__cpt_6__cpt_2__item_1__text_1

The manufacturer shall establish the technical documentation and make it available to the notified body referred to in point 6.4. The documentation shall make it possible to assess the instrument’s conformity with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the instrument. The technical documentation shall, wherever applicable, contain at least the following elements:

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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.