Medical Devices Ordinance
(MedDO)

¹ Man­u­fac­tur­ers or their au­thor­ised rep­res­ent­at­ives and im­port­ers must re­gister the in­form­a­tion re­quired by part A Sec­tion 1 of An­nex VI to EU-MDR⁹⁴ with Swiss­med­ic with­in three months of pla­cing a device on the mar­ket for the first time.

² The eco­nom­ic op­er­at­or in ques­tion must re­port any changes to the in­form­a­tion to Swiss­med­ic with­in one week.

³ Fur­ther ob­lig­a­tions and re­gis­tra­tion mod­al­it­ies are gov­erned by Art­icles 30 para­graph 3 and 31 EU-MDR.

⁴Swiss­med­ic shall veri­fy the in­form­a­tion provided by the eco­nom­ic op­er­at­ors and as­sign them a Swiss single re­gis­tra­tion num­ber (CHRN).⁹⁵

⁵ Any nat­ur­al or leg­al per­son pla­cing sys­tems and pro­ced­ure packs on the mar­ket for the first time un­der Art­icle 11 must re­gister their name and the ad­dress at which they can be con­tac­ted with Swiss­med­ic with­in three months of pla­cing the sys­tem or pro­ced­ure pack on the mar­ket. Where an au­thor­ised rep­res­ent­at­ive is re­quired un­der Art­icle 51 para­graph 5,the name and ad­dress of the au­thor­ised rep­res­ent­at­ive must also be re­gistered with Swiss­med­ic.