Medical Devices Ordinance
(MedDO)

¹ Any pro­fes­sion­al us­ing devices must en­sure that the devices are main­tained and tested in ac­cord­ance with the reg­u­la­tions.

² Main­ten­ance must be car­ried out in ac­cord­ance with the prin­ciples of a qual­ity man­age­ment sys­tem, is to be or­gan­ised ap­pro­pri­ately, and must be guided in par­tic­u­lar by:

a.

the man­u­fac­turer's in­struc­tions;

b.

the par­tic­u­lar risk as­so­ci­ated with the device and its use.

³ For devices with a meas­ure­ment func­tion, test pro­ced­ures may be re­quired in ac­cord­ance with the Meas­ur­ing In­stru­ments Or­din­ance of 15 Feb­ru­ary 2006¹¹³.

⁴ Swiss­med­ic may is­sue and pub­lish re­quire­ments for main­ten­ance meas­ures. These re­quire­ments shall be deemed to con­sti­tute the cur­rent sci­entif­ic and tech­no­lo­gic­al stand­ards.