anx_III__cpt_1__cpt_12__cpt_5__cpt_4__text_3
The need for such additional visits, and the frequency thereof, will be determined on the basis of a visit control system operated by the notified body. In particular, the following factors must be considered in the visit control system:
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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.