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. 15 Classification

1 Devices shall be di­vided in­to classes I, IIa, IIb and III, tak­ing in­to ac­count the in­ten­ded pur­pose of the devices and their in­her­ent risks. This clas­si­fic­a­tion must com­ply with the pro­vi­sions of An­nex VIII to EU-MDR22.

2 The pro­ced­ure for resolv­ing dis­putes between the man­u­fac­turer and a des­ig­nated body as re­gards the clas­si­fic­a­tion of a device is gov­erned by Art­icle 51 para­graph 2 EU-MDR.

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

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