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. 105 In vitro diagnostic medical devices 101

1 Un­til such time as a cor­res­pond­ing spe­cial Or­din­ance is is­sued, in vitro dia­gnost­ic med­ic­al devices are sub­ject to the Med­ic­al Devices Or­din­ance of 17 Oc­to­ber 2001102, sub­ject to para­graphs 2 and 3.

2 In vitro dia­gnost­ic med­ic­al devices must not carry the name and ad­dress of the nat­ur­al or leg­al per­son who first places them on the Swiss mar­ket on their la­belling, out­er pack­aging or in­struc­tions for use if they carry the name and ad­dress of the nat­ur­al or leg­al per­son who places them on the mar­ket in an EU or EEA state.

3 In vitro dia­gnost­ic med­ic­al devices that have been no­ti­fied to the com­pet­ent au­thor­ity of an EU or EEA state in ac­cord­ance with Art­icle 6 para­graph 2 of the Med­ic­al Devices Or­din­ance of 17 Oc­to­ber 2001 do not have to be ad­di­tion­ally no­ti­fied to Swiss­med­ic.

101 Amended by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281).

102 See the foot­note to Art. 99 no 1.

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