anx_II__cpt_9__cpt_8
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 5.1, the information relating to the change referred to in point 5.5, as approved; the decisions and reports from the notified body referred to in points 5.5, 6.3 and 6.4.
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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.