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 technical documentation, the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications of the personnel concerned, etc.
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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.