Medical Devices Ordinance
(MedDO)

¹This Or­din­ance ap­plies to:

a.

med­ic­al devices and the as­so­ci­ated ac­cessor­ies, as defined in Art­icle 3;

b.

groups of products without an in­ten­ded med­ic­al pur­pose in ac­cord­ance with An­nex 1.

² In this Or­din­ance, the term devices is used to des­ig­nate the products defined in para­graph 1.

³ This Or­din­ance also ap­plies to:

a.

devices which, when placed on the mar­ket or put in­to ser­vice, in­cor­por­ate as an in­teg­ral part a medi­cin­al product that has an ac­tion an­cil­lary to that of the device;

b.

devices in­ten­ded to ad­min­is­ter a medi­cin­al product;

c.

devices man­u­fac­tured:

1.

from tis­sues or cells of an­im­al ori­gin, or their de­riv­at­ives, which are non-vi­able or are rendered non-vi­able,

2.

from de­riv­at­ives of tis­sues or cells of hu­man ori­gin that are non-vi­able or are rendered non-vi­able;

d.

devices which, when placed on the mar­ket or put in­to ser­vice, in­cor­por­ate as an in­teg­ral part non-vi­able tis­sues or non-vi­able cells of hu­man ori­gin or their de­riv­at­ives that have an ac­tion an­cil­lary to that of the device;

e.

devices that in­cor­por­ate as an in­teg­ral part an in vitro dia­gnost­ic med­ic­al device; such con­stitu­ent parts shall be sub­ject to the pro­vi­sions for in vitro med­ic­al devices.