Medical Devices Ordinance
(MedDO)


Open article in different language:  IT
Art. 81 Access rights

1 The fol­low­ing per­sons and agen­cies shall be giv­en on­line ac­cess to in­form­a­tion sys­tems provided this is ne­ces­sary for the ful­fil­ment of their re­spect­ive tasks:

a.
Swiss­med­ic staff em­ployed in vi­gil­ance and mar­ket sur­veil­lance and third parties man­dated to per­form tasks in this area;
b.
Swiss­med­ic staff em­ployed in ad­min­is­trat­ive pen­al law;
c.
Swiss­med­ic ad­min­is­trat­ors and man­dated third parties.

2 A log of per­sons and bod­ies gran­ted ac­cess to the in­form­a­tion sys­tems shall be kept. The data in this log shall be stored for two years.

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