Medical Devices Ordinance
(MedDO)

English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.

of 1 July 2020 (Status as of 26 May 2021)


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Art. 9 Devices manufactured and used in healthcare institutions

1 Devices man­u­fac­tured and used solely with­in health­care in­sti­tu­tions are deemed to have been put in­to ser­vice. Such devices are sub­ject to the per­tin­ent gen­er­al safety and per­form­ance re­quire­ments of An­nex I to EU-MDR15 but not to any of the oth­er re­quire­ments set out in this Or­din­ance, provided the re­quire­ments of Art­icle 5 para­graph 5 let­ters a–h EU-MDR are ful­filled.

2 Para­graph 1 does not ap­ply to devices man­u­fac­tured on an in­dus­tri­al scale.

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

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