anx_II__cpt_1__cpt_3__text_1
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured instruments with the technical documentation referred to in point 2 and with the requirements of this Directive that apply to them.
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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.