Medical Devices Ordinance
(MedDO)

¹ The safety re­port must con­tain:

a.

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

b.

a ra­tionale and de­scrip­tion of any pre­vent­ive and cor­rect­ive ac­tions taken.

² Throughout the life­time of the device con­cerned, the safety re­port must set out:

a.

the con­clu­sions of the be­ne­fit-risk de­term­in­a­tion;

b.

the key res­ults of post-mar­ket clin­ic­al fol­low-up;

c.

the total sales volume of the device;

d.

an es­tim­ate of the size of the pop­u­la­tion us­ing the device;

e.

char­ac­ter­ist­ics of the pop­u­la­tion in let­ter d;

f.

the fre­quency of device us­age, where prac­tic­able.

³ The safety re­port forms part of the tech­nic­al doc­u­ment­a­tion spe­cified in An­nexes II and III to EU-MDR⁷³. For cus­tom-made devices, the re­port forms part of the doc­u­ment­a­tion spe­cified in Sec­tion 2 of An­nex XIII to EU-MDR.