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anx_IV__cpt_1__cpt_4__item_3__text_1

The notified body shall carry out periodic audits of at least once every two years to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.

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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.