Medical Devices Ordinance
(MedDO)

¹ Man­u­fac­tur­ers must en­sure that the fol­low­ing are avail­able to the com­pet­ent au­thor­ity for at least ten years after the last device covered by the de­clar­a­tion of con­form­ity has been placed on the mar­ket:

a.

com­plete tech­nic­al doc­u­ment­a­tion;

b.

de­clar­a­tion of con­form­ity;

c.

a copy of the cer­ti­fic­ates is­sued, in­clud­ing any amend­ments and sup­ple­ments.

² The doc­u­ment re­ten­tion peri­od for im­plant­able devices shall be at least 15 years from the date the last device was placed on the mar­ket.