Medical Devices Ordinance
(MedDO)


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Art. 35 Assessment report

1 If Swiss­med­ic ap­proves the plans re­quired un­der Art­icle 34 para­graph 2, it shall pre­pare an as­sess­ment re­port.

2 This shall com­prise the fol­low­ing:

a.
the res­ult of the as­sess­ment;
b.
con­firm­a­tion that suit­able cor­rect­ive and pre­vent­ive ac­tions have been ap­pro­pri­ately ad­dressed and, where ne­ces­sary, im­ple­men­ted;
c.
the scope of the des­ig­na­tion.
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