Medical Devices Ordinance
(MedDO)

¹ Devices offered in Switzer­land by means of an in­form­a­tion so­ci­ety ser­vice – spe­cific­ally an on­line ser­vice – that ful­fil the con­di­tions set out in para­graph 4 must com­ply with this Or­din­ance.²¹

^1bisDevices offered to users in Switzer­land on­line or via some oth­er form of dis­tance sales are con­sidered to be made avail­able on the mar­ket.²²

² Sim­il­arly, devices that are not placed on the mar­ket but are used in the con­text of a com­mer­cial activ­ity, wheth­er in re­turn for pay­ment or free of charge, for the pro­vi­sion of a dia­gnost­ic or thera­peut­ic ser­vice offered by means of in­form­a­tion so­ci­ety ser­vices or by oth­er means of com­mu­nic­a­tion must also com­ply with this Or­din­ance.

³ Upon re­quest by Swiss­med­ic, any nat­ur­al or leg­al per­son of­fer­ing a device in ac­cord­ance with para­graph 1 or provid­ing dia­gnost­ic or thera­peut­ic ser­vices in ac­cord­ance with para­graph 2 must provide a copy of the de­clar­a­tion of con­form­ity.²³

⁴ A device is deemed to be sup­plied via an in­form­a­tion so­ci­ety ser­vice if that ser­vice:

a.

is provided by dis­tance selling, spe­cific­ally without the con­tract­ing parties be­ing phys­ic­ally present at the same time;

b.

is provided elec­tron­ic­ally; and

c.

is provided at the in­di­vidu­al re­quest of the re­cip­i­ent or the re­cip­i­ent’s rep­res­ent­at­ive.

⁵ ...²⁴