Medical Devices Ordinance
(MedDO)

¹ Health­care in­sti­tu­tions that man­u­fac­ture and use devices as spe­cified in Art­icle 9 shall provide the fol­low­ing in­form­a­tion to Swiss­med­ic pri­or to put­ting the devices in­to ser­vice:

a.

their name and ad­dress;

b.

the name and in­ten­ded pur­pose of the device;

c.

the risk class of the device in ac­cord­ance with Art­icle 15 para­graph 1.

² Any oth­er rel­ev­ant in­form­a­tion about these devices must be sub­mit­ted to Swiss­med­ic at Swiss­med­ic’s re­quest. The de­clar­a­tion re­quired un­der Art­icle 5 para­graph 5 let­ter e EU-MDR³¹ must be made pub­licly avail­able.

³ Changes to the in­form­a­tion re­quired in para­graph 1 must be re­por­ted to Swiss­med­ic with­in 30 days.

⁴ De­pend­ing on the risk in­her­ent in a device and its use, Swiss­med­ic may ex­empt devices man­u­fac­tured and used in ac­cord­ance with Art­icle 9 from the re­port­ing ob­lig­a­tion.