Medical Devices Ordinance
(MedDO)

¹ In­spec­tions un­der the aus­pices of mar­ket sur­veil­lance shall cov­er devices made avail­able on the mar­ket, con­form­ity as­sess­ment pro­ced­ures, device sur­veil­lance, device hand­ling and eco­nom­ic op­er­at­ors’ ful­fil­ment of their ob­lig­a­tions. They shall also cov­er devices made avail­able in con­tract­ing states by nat­ur­al or leg­al per­sons dom­i­ciled in Switzer­land, the con­form­ity as­sess­ment pro­ced­ures and sur­veil­lance activ­it­ies for such devices and the nat­ur­al or leg­al per­sons’ ful­fil­ment of their ob­lig­a­tions.

² The mar­ket sur­veil­lance activ­it­ies un­der­taken by Swiss­med­ic and the Can­tons are gov­erned by Art­icle 66 TPA and Art­icles 93–95, 97 and 98 EU MDR¹¹⁵. Art­icles 97 para­graph 3 and 98 para­graphs 3 and 4 EU MDR are ex­cluded.¹¹⁶

³ The Can­tons shall draw up an­nu­al plans for their mar­ket sur­veil­lance activ­it­ies un­der para­graph 2. They shall provide Swiss­med­ic with an an­nu­al sum­mary of the res­ults of their sur­veil­lance activ­it­ies. Swiss­med­ic may de­term­ine both the con­tent of the sum­mary and the form in which it is made avail­able.

⁴ In case of an ac­tu­al ne­ces­sity for the pro­tec­tion of pub­lic health, Swiss­med­ic shall de­cree the meas­ures un­der Art­icle 66 TPA in a gen­er­al rul­ing.