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

¹ The Agency, to ful­fil its tasks, shall op­er­ate a med­ic­al devices in­form­a­tion sys­tem; this shall serve in par­tic­u­lar to en­sure the safety of med­ic­al devices, as well as vi­gil­ance and sur­veil­lance.

² The in­form­a­tion sys­tem shall con­tain data as spe­cified in Art­icle 62a which is ne­ces­sary for the sur­veil­lance of med­ic­al devices and the con­duct of no­ti­fic­a­tion and au­thor­isa­tion pro­ced­ures for clin­ic­al tri­als in ac­cord­ance with this Act.

³ The data re­ferred to in para­graph 2 may be auto­mat­ic­ally aligned with Eu­damed.

⁴ Any data re­ferred to in para­graph 2 which is not sens­it­ive may be pub­lished with due pro­tec­tion of pro­fes­sion­al con­fid­en­ti­al­ity and trade secrets.

⁵ The Fed­er­al Coun­cil shall reg­u­late:

a.

the struc­ture and data cata­logue;

b.

the ac­cess rights;

c.

the or­gan­isa­tion­al and tech­nic­al meas­ures ne­ces­sary to en­sure data pro­tec­tion and data se­cur­ity;

d.

the stor­age peri­od.