Medical Devices Ordinance
(MedDO)


Open article in different language:  IT
Art. 78 Duty to cooperate and provide information

1 Eco­nom­ic op­er­at­ors that place a device on the mar­ket in Switzer­land or in a con­tract­ing state, and eco­nom­ic op­er­at­ors, pro­fes­sion­als and health­care in­sti­tu­tions that make a device avail­able or put it in­to ser­vice in Switzer­land or a con­tract­ing state have a duty to co­oper­ate on mat­ters of en­force­ment. In par­tic­u­lar, they must provide, free of charge, all ne­ces­sary in­form­a­tion and all ne­ces­sary proof and doc­u­ment­a­tion to the en­force­ment bod­ies.

2The pro­viders of in­form­a­tion so­ci­ety ser­vices also have a duty to co­oper­ate on mat­ters of en­force­ment. In par­tic­u­lar, they should in­form the com­pet­ent au­thor­it­ies about sus­pec­ted il­leg­al activ­it­ies by, or in­form­a­tion from, users of their ser­vice and, upon re­quest, provide in­form­a­tion that en­ables the users of their ser­vice with whom they have con­cluded agree­ments about stor­age to be iden­ti­fied.121

121 In­ser­ted by An­nex 5 No 1 of the O of 4 May 2022 on In Vitro Dia­gnost­ic Med­ic­al Devices, in force since 26 May 2022 (AS 2022 291).

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