Medical Devices Ordinance
(MedDO)

¹ Man­u­fac­tur­ers of class I devices must draw up a post-mar­ket sur­veil­lance re­port.

² This re­port must con­tain:

a.

a sum­mary of the res­ults and con­clu­sions of the ana­lyses of the data gathered as a res­ult of the plan spe­cified in Art­icle 58;

b.

a de­scrip­tion of any pre­vent­ive and cor­rect­ive ac­tions taken, in­clud­ing their ra­tionale.

³ The re­port forms part of the post-mar­ket sur­veil­lance tech­nic­al doc­u­ment­a­tion spe­cified in An­nex III to EU-MDR⁹⁸.

⁴ The man­u­fac­turer must up­date the re­port when ne­ces­sary and make it avail­able to the com­pet­ent au­thor­ity upon re­quest.