Medical Devices Ordinance
(MedDO)


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Art. 108 Notification of devices, systems and procedure packs 163

1 Un­til Art­icle 17 para­graph 5 enters in­to force, the fol­low­ing no­ti­fic­a­tion ob­lig­a­tions shall con­tin­ue to ap­ply to nat­ur­al or leg­al per­sons dom­i­ciled in Switzer­land:

a.
for man­u­fac­tur­ers and nat­ur­al or leg­al per­sons who as­semble sys­tems or pro­ced­ure packs un­der Art­icle 22 para­graphs 1 and 3 EU-MDR164: the no­ti­fic­a­tion ob­lig­a­tions set out in Art­icle 6 para­graphs 1 and 4 of the Med­ic­al Devices Or­din­ance of 17 Oc­to­ber 2001165:
b.
for nat­ur­al or leg­al per­sons who place med­ic­al devices on the mar­ket un­der Art­icle 2 para­graph 1 of the Med­ic­al Devices Or­din­ance of 17 Oc­to­ber 2001: the no­ti­fic­a­tion ob­lig­a­tions set out in Art­icle 6 para­graphs 3 and 4 of the Med­ic­al Devices Or­din­ance of 17 Oc­to­ber 2001.

2 ...166

163 Amended by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281).

164 See the foot­note to Art. 4 para. 1 let. f.

165 See the foot­note to Art. 99 no 1.

166 Comes in­to force at a later date (Art. 110 para. 2).

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