Medical Devices Ordinance
(MedDO)

¹ Devices placed on the mar­ket in Switzer­land or made avail­able on the Swiss mar­ket must bear a con­form­ity mark­ing in ac­cord­ance with An­nex 5. The con­form­ity mark­ing presen­ted in An­nex V to EU-MDR¹⁸ is also a per­miss­ible con­form­ity mark­ing.

² The fol­low­ing must not bear a con­form­ity mark­ing:

a.

cus­tom-made devices;

b.

devices ex­clus­ively for demon­stra­tion and ex­hib­i­tion pur­poses;

c.

sys­tems and pro­ced­ure packs;

d.

in­vest­ig­a­tion­al devices, sub­ject to the pro­vi­sions of Art­icle 6 of the Or­din­ance of 1 Ju­ly 2020¹⁹ on Clin­ic­al Tri­als with Med­ic­al Devices;

e.

devices man­u­fac­tured and used in health­care in­sti­tu­tions.

³ Where devices’ con­form­ity has to be as­sessed by a des­ig­nated body, the iden­ti­fic­a­tion num­ber of this body must be ap­pen­ded to the con­form­ity mark­ing.