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

¹ The man­u­fac­turer must pro­duce tech­nic­al doc­u­ment­a­tion.

² The tech­nic­al doc­u­ment­a­tion must be such as to per­mit an as­sess­ment of the con­form­ity of the med­ic­al device with the re­quire­ments of this Act. In par­tic­u­lar, it shall also con­tain in­form­a­tion and data on post-mar­ket sur­veil­lance.

³ The man­u­fac­turer must keep the tech­nic­al doc­u­ment­a­tion up to date.

⁴ The Fed­er­al Coun­cil shall spe­cify for what med­ic­al devices what data and in­form­a­tion must be in­cluded in the tech­nic­al doc­u­ment­a­tion, and how this doc­u­ment­a­tion must be made avail­able.