Medical Devices Ordinance
(MedDO)

¹ For the pur­poses of veri­fy­ing con­form­ity, the au­thor­it­ies re­spons­ible for mon­it­or­ing un­der Art­icle 76 may, without provid­ing com­pens­a­tion:

a.

de­mand the proof and in­form­a­tion re­quired;

b.

take samples;

c.

have the samples tested or sub­mit­ted to labor­at­ory ex­am­in­a­tion;

d.

enter and in­spect, dur­ing nor­mal work­ing hours and with ad­vance no­tice or, if ne­ces­sary, un­an­nounced, the busi­ness premises and fa­cil­it­ies of nat­ur­al or leg­al per­sons who have an ob­lig­a­tion to provide in­form­a­tion;

e.

con­sult doc­u­ments and de­mand that they, or ad­di­tion­al in­form­a­tion, be provided in one of the of­fi­cial lan­guages of Switzer­land or in Eng­lish.

² If a man­u­fac­turer or a nat­ur­al or leg­al per­son who as­sembles sys­tems or pro­ced­ure packs un­der Art­icle 22 para­graphs 1 and 3 EU-MDR¹¹⁹ fails to ful­fil their ob­lig­a­tions un­der Art­icle 66, Swiss­med­ic may im­pose ap­pro­pri­ate meas­ures to pro­tect health, up to and in­clud­ing pro­hib­it­ing the mak­ing avail­able on the mar­ket or the put­ting in­to ser­vice of the devices in ques­tion.¹²⁰