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anx_III__cpt_1__cpt_8__cpt_6__item_4__text_2

the category of the equipment, the results of previous surveillance visits, the need to follow up corrective action(s), special conditions linked to the approval of the system, where applicable, significant changes in manufacturing organisation, policy or techniques.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-02 · Text as adopted (Official Journal); later amendments are not incorporated in this text.