Medical Devices Ordinance
(MedDO)

¹ Im­port­ers may only place on the mar­ket devices that com­ply with this Or­din­ance. Be­fore pla­cing devices on the mar­ket, they shall veri­fy that:

a.

the device bears the con­form­ity mark­ing;

b.

the de­clar­a­tion of con­form­ity has been drawn up;

c.

the man­u­fac­turer is iden­ti­fied and has des­ig­nated an au­thor­ised rep­res­ent­at­ive in ac­cord­ance with Art­icle 51;

d.

the device is la­belled in ac­cord­ance with this Or­din­ance and ac­com­pan­ied by in­struc­tions for use;

e.

the man­u­fac­turer has as­signed a UDI where ap­plic­able.

² Im­port­ers shall in­dic­ate on the device or on its pack­aging or in a doc­u­ment ac­com­pa­ny­ing the device, their name, place of busi­ness and the ad­dress at which they can be con­tac­ted.

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

⁴ The fur­ther ob­lig­a­tions of im­port­ers pri­or to and after pla­cing a device on the mar­ket are gov­erned by Art­icles 13 and 16 para­graphs 3 and 4 EU-MDR⁹¹. In par­tic­u­lar, im­port­ers must com­ply with the fol­low­ing ob­lig­a­tions:

a.

stor­age, trans­port and qual­ity man­age­ment sys­tem;

b.

co­oper­a­tion with the man­u­fac­turer, au­thor­ised rep­res­ent­at­ive, des­ig­nated body and com­pet­ent au­thor­it­ies;

c.

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