Medical Devices Ordinance
(MedDO)

¹ Should it be­come evid­ent in the course of post-mar­ket sur­veil­lance that pre­vent­ive and/or cor­rect­ive ac­tions are ne­ces­sary, the man­u­fac­turer shall im­ple­ment the ap­pro­pri­ate meas­ures and in­form the com­pet­ent au­thor­it­ies and, if ap­plic­able, the des­ig­nated body.

² If a man­u­fac­turer be­comes aware of a ser­i­ous in­cid­ent in con­nec­tion with a device that has been made avail­able on the mar­ket, or takes ac­tion to pre­vent or min­im­ise the risk of such an in­cid­ent for med­ic­al or tech­nic­al reas­ons (field safety cor­rect­ive ac­tions), it must re­port the fact in ac­cord­ance with Art­icle 66.