Medical Devices Ordinance
(MedDO)

¹ In re­sponse to a jus­ti­fied ap­plic­a­tion, Swiss­med­ic may au­thor­ise the pla­cing on the mar­ket and put­ting in­to ser­vice of a spe­cif­ic device the use of which is in the in­terests of pub­lic health or pa­tient safety or health even though:

a.

the rel­ev­ant con­form­ity as­sess­ment pro­ced­ure ac­cord­ing to Art­icle 23 has not been car­ried out; or

b.

the lan­guage re­quire­ments in Art­icle 16 para­graph 2 have not been met.

² In­di­vidu­al devices that have not un­der­gone the rel­ev­ant con­form­ity as­sess­ment pro­ced­ure may be placed on the mar­ket and used without au­thor­isa­tion from Swiss­med­ic provided:

a.

they serve to avert life-threat­en­ing con­di­tions or to re­solve the per­man­ent impair­ment of a bod­ily func­tion;

b.

no con­form­ing device is avail­able for this spe­cif­ic in­dic­a­tion;

c.

they are used ex­clus­ively by health­care pro­fes­sion­als on in­di­vidu­al per­sons;

d.

the health­care pro­fes­sion­al us­ing the device has in­formed the in­di­vidu­al con­cerned about the non-con­form­ity of the med­ic­al device and the re­lated risks; and

e.

the in­di­vidu­al con­cerned has con­sen­ted to the use of the device.

³ For devices placed on the mar­ket ex­clus­ively with­in the armed forces or with­in the frame­work of their spe­cif­ic tasks, the Fed­er­al De­part­ment of Home Af­fairs (FDHA) may, in agree­ment with the Fed­er­al De­part­ment of De­fence, Civil Pro­tec­tion and Sports, grant ex­emp­tions.