By Pavel Boček
Proces posouzení shody a jeho délka však závisí na kvalitě poskytnuté dokumentace. V případě, že je nutné požádat o stanovisko kompetentní autoritu (např. obsahuje-li zdravotnický prostředek jako integrální součást léčivo nebo pokud se může jednat o hraniční výrobek apod.), se doba posouzení zdravotnického prostředku prodlužuje v závislosti na lhůtě její odpovědi.
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