Medical Devices Ordinance
(MedDO)

¹ Product in­form­a­tion com­prises the la­belling and in­struc­tions for use. It is gov­erned by Chapter III of An­nex I to EU-MDR³⁸.

² It must be writ­ten in all three of­fi­cial lan­guages of Switzer­land. Sym­bols es­tab­lished by means of tech­nic­al stand­ards may be used to re­place writ­ten state­ments.

³ The product in­form­a­tion may be provided in few­er than the three of­fi­cial lan­guages of Switzer­land or in Eng­lish, provided that:

a.³⁹

the device is sup­plied ex­clus­ively to health­care pro­fes­sion­als or is a cus­tom-made device or con­cerns a med­ic­al device in ac­cord­ance with Art­icle 9;

b.⁴⁰

the user meets the ne­ces­sary pro­fes­sion­al and lin­guist­ic re­quire­ments and qual­i­fic­a­tions, and is in agree­ment;

c.

the pro­tec­tion of pa­tients, users and third parties is en­sured; and

d.

the ef­fic­acy and per­form­ance of the med­ic­al device are not placed at risk.

⁴ If re­ques­ted, ad­di­tion­al in­form­a­tion must be provided to users in one of the of­fi­cial lan­guages of Switzer­land.

⁵ If a product can­not be, or can­not yet be, placed on the mar­ket as a med­ic­al device but may be con­fused with such a device, the claims re­lat­ing to the said product must in­dic­ate clearly and legibly that it is not a med­ic­al device and is not suit­able for med­ic­al pur­poses.

⁶ Devices in­ten­ded solely for demon­stra­tion and present­a­tion pur­poses must be spe­cific­ally la­belled as such. The in­form­a­tion must be clearly vis­ible and com­pre­hens­ible.

⁷ Mis­lead­ing or con­tra­dict­ory in­form­a­tion on a device’s in­ten­ded pur­pose, safety and per­form­ance is for­bid­den.