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anx_III__cpt_1__cpt_3__cpt_4__cpt_2

3.4.2. The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular: the quality system documentation; the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-01 · Text as adopted (Official Journal); later amendments are not incorporated in this text.