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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 referred to in point 5.2; the technical documentation referred to in point 2; the quality records, such as inspection reports and calculation, measurement and test data, calibration data and qualification reports on the personnel concerned.

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Source: EUR-Lex (Cellar) · retrieved 2026-09-29 · Text as consolidated on 2026-08-13; changes after this date are not shown.