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anx_II__cpt_1__cpt_3__cpt_8

3.8. The manufacturer shall, for a period ending 10 years after the instrument has been placed on the market, keep at the disposal of the national authorities: the documentation referred to in point 3.5.1; the information relating to the change referred to in point 3.5.5, as approved; the decisions and reports of the notified body referred to in points 3.5.5, 3.6.3 and 3.6.4.

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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.