Medical Devices Ordinance
(MedDO)

¹ This med­ic­al devices in­form­a­tion sys­tem con­tains the fol­low­ing data:

a.

device data;

b.

data on eco­nom­ic op­er­at­ors;

c.

data on the des­ig­nated bod­ies and cer­ti­fic­ates is­sued by them;

d.

data on clin­ic­al tri­als;

e.

vi­gil­ance data;

f.

mar­ket sur­veil­lance data;

g.

data that can be used to man­age and ad­apt the med­ic­al devices in­form­a­tion sys­tem (sys­tem data);

h.

au­then­tic­a­tion data, as­signed user roles and ba­sic set­tings for us­ing the med­ic­al devices in­form­a­tion sys­tem (user data).

² The med­ic­al devices in­form­a­tion sys­tem only con­tains per­son­al data where such data are re­quired to re­cord and pro­cess in­form­a­tion.