Medical Devices Ordinance
(MedDO)

¹ Hos­pit­als must set up an in­tern­al re­port­ing sys­tem with­in the frame­work of an es­tab­lished qual­ity man­age­ment sys­tem for the pur­pose of re­port­ing un­der Art­icle 66 para­graph 4.

² They must des­ig­nate a suit­able com­pet­ent per­son (vi­gil­ance con­tact per­son) with a med­ic­al or tech­nic­al qual­i­fic­a­tion to as­sume re­spons­ib­il­ity for re­port­ing to Swiss­med­ic. They must sup­ply this per­son’s con­tact de­tails to Swiss­med­ic.

³ Re­cords and all doc­u­ments cre­ated un­der the vi­gil­ance qual­ity man­age­ment sys­tem must be re­tained for at least 15 years.