Federal Act
on Medicinal Products and Medical Devices
(Therapeutic Products Act, TPA)

¹ Any per­son who uses a med­ic­al device com­mer­cially or who uses it on a third party shall be ob­liged to take all the ne­ces­sary meas­ures for the main­ten­ance of such device to en­sure the con­tin­ued per­form­ance and the safety of the med­ic­al device.

² The Fed­er­al Coun­cil may:

a.

spe­cify the type of main­ten­ance re­quired for cer­tain med­ic­al devices or cer­tain classes of med­ic­al devices;

b.

reg­u­late the pro­ced­ure for prov­ing that the ob­lig­a­tion of main­ten­ance and the re­l­at­ive re­quire­ments have been ful­filled;

c.

make the main­ten­ance de­pend­ent upon the tech­nic­al con­di­tions.