Medical Devices Ordinance
(MedDO)


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Art. 8 Specific requirements

1 Devices without an in­ten­ded med­ic­al pur­pose in ac­cord­ance with Art­icle 1 para­graph 1 let­ter b must com­ply with the com­mon spe­cific­a­tions stip­u­lated by Swiss­med­ic.

2 Devices that have both a med­ic­al and non-med­ic­al in­ten­ded pur­pose must ful­fil both the re­quire­ments for devices with an in­ten­ded med­ic­al pur­pose and the re­quire­ments for devices without an in­ten­ded med­ic­al pur­pose.

3 Devices that are also ma­chines with­in the mean­ing of Art­icle 1 of the Ma­chine Or­din­ance of 2 April 200825 must sat­is­fy the per­tin­ent gen­er­al safety and health pro­tec­tion re­quire­ments of the Ma­chine Or­din­ance where these re­quire­ments are more spe­cif­ic than those of Chapter II of An­nex I to EU-MDR26.

25 SR 819.14

26 See the foot­note to Art. 4 para. 1 let. f.

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