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4.2.

The manufacturer shall for assessment purposes allow the notified body access to the premises where final inspection, testing and storage are carried out and provide it with all necessary information, in particular: the quality system documentation; the technical documentation; the quality records, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned.

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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.