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

¹ A med­ic­al device used in ac­cord­ance with its in­ten­ded use must not en­danger the health of the user, the con­sumer, the pa­tient or a third party. The in­ten­ded per­form­ance must be demon­strated.¹⁰²

² Any per­son pla­cing a med­ic­al device on the mar­ket must be able to prove that the device sat­is­fies the fun­da­ment­al re­quire­ments.

³ The Fed­er­al Coun­cil shall lay down the re­quire­ments that med­ic­al devices must sat­is­fy. In par­tic­u­lar it shall lay down:

a¹⁰³.

the fun­da­ment­al safety and per­form­ance re­quire­ments;

b.

the rules of their clas­si­fic­a­tion;

c.

the lan­guages used for the product in­form­a­tion;

d.¹⁰⁴

the product la­belling.

⁴ The Agency shall, in con­sulta­tion with the State Sec­ret­ari­at for Eco­nom­ic Af­fairs, des­ig­nate tech­nic­al stand­ards and com­mon spe­cific­a­tions which are ap­pro­pri­ate for giv­ing con­crete form to the fun­da­ment­al re­quire­ments. It shall des­ig­nate, as far as pos­sible, in­ter­na­tion­ally har­mon­ised stand­ards. It shall pub­lish in the Fed­er­al Gaz­ette the titles of the des­ig­nated tech­nic­al stand­ards and com­mon spe­cific­a­tions, also in­dic­at­ing the ref­er­ences or where they may be ob­tained.¹⁰⁵

⁵ The Fed­er­al Coun­cil shall lay down the re­quire­ments for med­ic­al devices in­ten­ded for use in clin­ic­al tri­als.

⁶ It may provide for the re­lax­a­tion of re­quire­ments for med­ic­al devices pro­duced and used only with­in health in­sti­tu­tions.¹⁰⁶

⁷ It may provide for the per­miss­ib­il­ity of re­pro­cessing and fur­ther use of single-use devices. It shall spe­cify the rel­ev­ant con­di­tions.¹⁰⁷