Medical Devices Ordinance
(MedDO)

¹ Any nat­ur­al or leg­al per­son who makes cus­tom-made devices avail­able on the Swiss mar­ket must provide the fol­low­ing in­form­a­tion to Swiss­med­ic be­fore mak­ing the devices avail­able:

a.

the name and ad­dress of the man­u­fac­turer and all man­u­fac­tur­ing sites;

b.

the name and ad­dress of the au­thor­ised rep­res­ent­at­ive if ap­plic­able;

c.

the codes re­quired to identi­fy the rel­ev­ant product cat­egor­ies, as spe­cified by the European Com­mis­sion by means of im­ple­ment­ing acts⁵².

² Changes to this in­form­a­tion must be re­por­ted to Swiss­med­ic with­in 30 days of the changes tak­ing ef­fect.

³ De­pend­ing on the risk in­her­ent to a device and its use, Swiss­med­ic may ex­empt cus­tom-made devices from the re­port­ing ob­lig­a­tion un­der para­graph 1.