Medical Devices Ordinance
(MedDO)

English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.

of 1 July 2020 (Status as of 26 May 2021)


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Art. 59 Report

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

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 ra­tionale and de­scrip­tion of any pre­vent­ive and cor­rect­ive ac­tions taken.

3 The re­port forms part of the post-mar­ket sur­veil­lance tech­nic­al doc­u­ment­a­tion spe­cified in An­nex III to EU-MDR72.

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

72 See the foot­note to Art. 4 para. 1 let. f.

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