Medical Devices Ordinance
(MedDO)

¹ When a des­ig­nated body is in­volved, all the in­form­a­tion ne­ces­sary for the con­form­ity as­sess­ment must be made avail­able to it.

² Man­u­fac­tur­ers must not ap­ply to more than one des­ig­nated body in Switzer­land or a con­tract­ing state to con­duct a con­form­ity as­sess­ment pro­ced­ure for the same product.

³ Any nat­ur­al or leg­al per­son who ap­plies to a des­ig­nated body must in­form that body wheth­er an ap­plic­a­tion to a dif­fer­ent des­ig­nated body in Switzer­land or a con­tract­ing state has been with­drawn be­fore a de­cision was is­sued or re­jec­ted by a dif­fer­ent des­ig­nated body in Switzer­land or a con­tract­ing state.

⁴ If a man­u­fac­turer with­draws its ap­plic­a­tion to have a con­form­ity as­sess­ment pro­ced­ure con­duc­ted be­fore the des­ig­nated body has is­sued its de­cision on the as­sess­ment, the des­ig­nated body in ques­tion will no­ti­fy Swiss­med­ic and the oth­er des­ig­nated bod­ies.

⁵ The in­form­a­tion re­quired in para­graph 4 must be sup­plied ex­clus­ively via Eu­damed.

⁶ Where a man­u­fac­turer vol­un­tar­ily changes des­ig­nated body, it must com­ply with the re­quire­ments of Art­icle 58 EU-MDR³⁸.