Medical Devices Ordinance
(MedDO)

¹ In this Or­din­ance:

a.

mak­ing avail­able on the mar­ket means any trans­fer or ces­sion of a device, oth­er than an in­vest­ig­a­tion­al device, for dis­tri­bu­tion, con­sump­tion or use on the Swiss mar­ket in the course of a com­mer­cial activ­ity, wheth­er in re­turn for pay­ment or free of charge;

b.

pla­cing on the mar­ket means the first mak­ing avail­able of a device, oth­er than an in­vest­ig­a­tion­al device, on the Swiss mar­ket;

c.

put­ting in­to ser­vice means the stage at which a device, oth­er than an in­vest­ig­a­tion­al device, has been made avail­able to the fi­nal user as be­ing ready for use on the Swiss mar­ket for the first time for its in­ten­ded pur­pose;

d.

main­ten­ance means meas­ures such as pre­vent­ive main­ten­ance, soft­ware up­dates, in­spec­tion, re­pair, pre­par­a­tion for first use and re­pro­cessing for re­use or meas­ures to keep a device in func­tion­al con­di­tion or re­store it to func­tion­al con­di­tion;

e.

re­pro­cessing means a pro­cess car­ried out on a used device in or­der to al­low its safe re­use in­clud­ing clean­ing, dis­in­fec­tion, ster­il­isa­tion and re­lated pro­ced­ures, par­tic­u­larly pack­ing, trans­port and stor­age, as well as test­ing and restor­ing the tech­nic­al and func­tion­al safety of the used device;

f.

man­u­fac­turer means a nat­ur­al or leg­al per­son who man­u­fac­tures or fully re­fur­bishes a device or has a device de­signed, man­u­fac­tured or fully re­fur­bished, and mar­kets that device un­der its name or trade­mark; this defin­i­tion is sub­ject to the cla­ri­fy­ing ex­plan­a­tions and ex­cep­tions in Art­icle 16 para­graphs 1 and 2 of Reg­u­la­tion (EU) 2017/745¹¹ on med­ic­al devices (EU-MDR);

g.

au­thor­ised rep­res­ent­at­ive means any nat­ur­al or leg­al per­son dom­i­ciled in Switzer­land who has re­ceived and ac­cep­ted a writ­ten man­date from a man­u­fac­turer loc­ated in an­oth­er coun­try to act on the man­u­fac­turer's be­half in re­la­tion to spe­cified tasks with re­gard to the lat­ter's ob­lig­a­tions un­der this Or­din­ance;

h.

im­port­er means any nat­ur­al or leg­al per­son dom­i­ciled in Switzer­land that places a device from a for­eign coun­try on the Swiss mar­ket;

i.

dis­trib­ut­or means any nat­ur­al or leg­al per­son in the sup­ply chain, oth­er than the man­u­fac­turer or the im­port­er, that makes a device avail­able on the Swiss mar­ket, up un­til the point of put­ting in­to ser­vice;

j.

eco­nom­ic op­er­at­or means the man­u­fac­turer, au­thor­ised rep­res­ent­at­ive, im­port­er, dis­trib­ut­or or the nat­ur­al or leg­al per­son re­ferred to in Art­icle 22 para­graphs 1 and 3 EU-MDR;

k.

health­care in­sti­tu­tion means an or­gan­isa­tion the primary pur­pose of which is the care or treat­ment of pa­tients or the pro­mo­tion of pub­lic health;

l.

hos­pit­almeans any health­care in­sti­tu­tion in which in­pa­tient treat­ments for ill­nesses, in­pa­tient med­ic­al re­hab­il­it­a­tion and in­pa­tient med­ic­al meas­ures for cos­met­ic pur­poses are provided by med­ic­al or nurs­ing in­ter­ven­tions;

m.

con­tract­ing state means any state that is bound to mu­tu­ally re­cog­nise con­form­ity as­sess­ments and con­form­ity pro­ced­ures for devices by an agree­ment with Switzer­land un­der in­ter­na­tion­al law based on equi­val­ent le­gis­la­tion;

n.¹²

pro­vider of in­form­a­tion so­ci­ety ser­vicesmeans any nat­ur­al or leg­al per­son who provides a ser­vice in ac­cord­ance with Art­icle 7 para­graph 4.

² The defin­i­tions set out in Art­icle 2 num­bers 3–26, 31, 37, 38, 40–44, 46, 48, 51–53, 57–69 and 71 EU-MDR, tak­ing ac­count of the amend­ments to the defin­i­tions in Art­icle 2 num­bers 18–21 EU-MDR, ad­op­ted by the European Com­mis­sion by means of del­eg­ated acts¹³.