Medical Devices Ordinance
(MedDO)

¹ Med­ic­al devicesarein­stru­ments, ap­par­at­us, ap­pli­ances, soft­wares, im­plants, re­agents, ma­ter­i­als or oth­er art­icles:

a.

that are in­ten­ded by their man­u­fac­turer to be used for hu­man be­ings;

b.

that do not achieve their prin­cip­al in­ten­ded ac­tion in or on the hu­man body by phar­ma­co­lo­gic­al, im­mun­o­lo­gic­al or meta­bol­ic means, but which may be as­sisted in their func­tion by such means; and

c.

that serve to ful­fil one or more of the fol­low­ing spe­cif­ic med­ic­al pur­poses either alone or in com­bin­a­tion:

1.

dia­gnos­is, pre­ven­tion, mon­it­or­ing, pre­dic­tion, pro­gnos­is, treat­ment or al­le­vi­ation of dis­ease,

2.

dia­gnos­is, mon­it­or­ing, treat­ment, al­le­vi­ation of, or com­pens­a­tion for, in­jur­ies or dis­ab­il­it­ies,

3.

in­vest­ig­a­tion, re­place­ment or modi­fic­a­tion of the ana­tomy or of a physiolo­gic­al or patho­lo­gic­al pro­cess or state,

4.

provid­ing in­form­a­tion by means of in vitro ex­am­in­a­tion of spe­ci­mens de­rived from the hu­man body, in­clud­ing or­gan, blood and tis­sue dona­tions.

²Med­ic­al devices also in­clude:

a.

devices for the con­trol or sup­port of con­cep­tion;

b.

products spe­cific­ally in­ten­ded for the clean­ing, dis­in­fec­tion or ster­il­isa­tion of devices as re­ferred to in Art­icle 1, para­graph 1 and in para­graph 1 of this Art­icle.

³ Ac­cess­ory for a med­ic­al device means an art­icle which, whilst not be­ing it­self a med­ic­al device, is in­ten­ded by its man­u­fac­turer to be used to­geth­er with one or more par­tic­u­lar med­ic­al devices and:

a.

which spe­cific­ally en­able the med­ic­al device or devices to be used in ac­cord­ance with its or their in­ten­ded pur­pose; or

b.¹⁰

which spe­cific­ally and dir­ectly as­sists the med­ic­al func­tion­al­ity of the med­ic­al device(s) in terms of its/their in­ten­ded pur­pose(s).