Medical Devices Ordinance
(MedDO)

¹ This Or­din­ance does not ap­ply to:

a.

hu­man blood, blood products, plasma or blood cells of hu­man ori­gin, or devices which in­cor­por­ate, when placed on the mar­ket or put in­to ser­vice, such blood products, plasma or cells ex­cept for devices re­ferred to in Art­icle 1 para­graph 3 let­ter a;

b.

vi­tal or­gans, tis­sues or cells and trans­plant products of hu­man ori­gin;

c.

vi­tal or­gans, tis­sues or cells and trans­plant products of an­im­al ori­gin;

d.

products oth­er than those re­ferred to in let­ters a–c that con­tain or con­sist of vi­able bio­lo­gic­al ma­ter­i­al or vi­able or­gan­isms, in­clud­ing liv­ing mi­cro-or­gan­isms, bac­teria, fungi or vir­uses, in or­der to achieve or sup­port the in­ten­ded pur­pose of the product;

e.

in vitro dia­gnost­ic med­ic­al devices; these are sub­ject to Art­icles 105 and 107;

f.

non-sep­ar­able com­bin­a­tions of a medi­cin­al product and device in­ten­ded to ad­min­is­ter a medi­cin­al product that are in­ten­ded solely for use in this com­bin­a­tion and are not re­usable;

g.

com­bin­a­tions which, when placed on the mar­ket or put in­to ser­vice, in­cor­por­ate as an in­teg­ral part a medi­cin­al product in ad­di­tion to the device, where the medi­cin­al product as­sumes a primary func­tion in such com­bin­a­tions;

h.

com­bin­a­tions 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 in ad­di­tion to the device, where such tis­sues, cells or de­riv­at­ives as­sume a primary func­tion in the device;

i.

med­ic­al devices in­ten­ded solely for use in an­im­als or veter­in­ary dia­gnostics;

j.⁸

com­bin­a­tions which, when placed on the mar­ket or put in­to ser­vice, in­cor­por­ate as an in­teg­ral part trans­plant products in ad­di­tion to the device.

² In the cases spe­cified in para­graph 1 let­ters f–h and j, the part of the com­bin­a­tion that is deemed to be a device must sat­is­fy the gen­er­al safety and per­form­ance re­quire­ments set out in Art­icle 6.⁹