Medical Devices Ordinance
(MedDO)

¹ When mak­ing a device avail­able on the mar­ket, dis­trib­ut­ors must, in the con­text of their activ­it­ies, act with due care in re­la­tion to the re­quire­ments ap­plic­able. Be­fore mak­ing a device avail­able on the mar­ket, dis­trib­ut­ors must veri­fy that:

a.

the device bears the con­form­ity mark­ing;

b.

the de­clar­a­tion of con­form­ity has been drawn up;

c.

the device is ac­com­pan­ied by the product in­form­a­tion;

d.

where devices have been im­por­ted the im­port­er has provided the in­form­a­tion re­quired in Art­icle 53 para­graph 2; and

e.

the man­u­fac­turer has as­signed a UDI where ap­plic­able.

² With the ex­cep­tion of para­graph 1 let­ter d, a sampling meth­od may be used for the pur­poses of veri­fic­a­tion.

³ Where a dis­trib­ut­or con­siders or has reas­on to be­lieve that a device is not in con­form­ity with the re­quire­ments of this Or­din­ance, it must not make the device avail­able on the mar­ket un­til it has been brought in­to con­form­ity.

⁴ The fur­ther ob­lig­a­tions of dis­trib­ut­ors pri­or to and after mak­ing a device avail­able on the mar­ket are gov­erned by Art­icles 14 and 16 para­graphs 3 and 4 EU-MDR⁹². In par­tic­u­lar, dis­trib­ut­ors must ful­fil the fol­low­ing ob­lig­a­tions:

a.

stor­age, trans­port and qual­ity man­age­ment sys­tem;

b.

co­oper­a­tion with the man­u­fac­turer, au­thor­ised rep­res­ent­at­ive, im­port­er and com­pet­ent au­thor­it­ies;

c.

the pro­vi­sion of in­form­a­tion to the man­u­fac­turer, au­thor­ised rep­res­ent­at­ive, im­port­er and com­pet­ent au­thor­it­ies.