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2. Technical documentation

The manufacturer shall establish the technical documentation as described in Article 18 and make it available to the notified body referred to in point 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 manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for 10 years after the instrument has been placed on the market.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.