Medical Devices Ordinance
(MedDO)

¹ Any nat­ur­al or leg­al per­son who makes avail­able on the mar­ket an item in­ten­ded to re­place an identic­al or sim­il­ar in­teg­ral part or com­pon­ent of a device that is de­fect­ive or worn in or­der to main­tain or re­store the func­tion of the device without chan­ging its per­form­ance or safety char­ac­ter­ist­ics or its in­ten­ded pur­pose shall en­sure that the item does not ad­versely af­fect the safety and per­form­ance of the device. Sup­port­ing evid­ence must be kept avail­able for the com­pet­ent au­thor­ity.

² An item that is in­ten­ded spe­cific­ally to re­place a part or com­pon­ent of a device and that sig­ni­fic­antly changes the per­form­ance or safety char­ac­ter­ist­ics or the in­ten­ded pur­pose of the device shall be con­sidered to be a device and shall meet the re­quire­ments laid down in this Or­din­ance.