Medical Devices Ordinance
(MedDO)

¹ Man­u­fac­tur­ers shall make their safety re­ports avail­able to the des­ig­nated body in­volved in the con­form­ity as­sess­ment.

² The des­ig­nated body shall re­view the safety re­port for class III devices or im­plant­able devices and re­cord the out­come of its re­view with de­tails of any ac­tion taken.

³ Man­u­fac­tur­ers or their au­thor­ised rep­res­ent­at­ives shall, upon re­quest, make the safety re­port and the out­come of the des­ig­nated body’s re­view, with de­tails of any ac­tion taken, avail­able to the com­pet­ent au­thor­ity.