Medical Devices Ordinance
(MedDO)

¹ Swiss­med­ic shall con­duct an on-site as­sess­ment of the con­form­ity as­sess­ment body and, if rel­ev­ant, of all sub-con­tract­ors and sub­si­di­ar­ies.

² If Swiss­med­ic iden­ti­fies non-com­pli­ances in the course of its as­sess­ment, it shall draw up a list of non-com­pli­ances for the ap­plic­ant. Swiss­med­ic shall set the con­form­ity as­sess­ment body a dead­line by which the lat­ter shall sub­mit to Swiss­med­ic a cor­rect­ive ac­tion plan to rem­edy the non-com­pli­ances and a pre­vent­ive ac­tion plan.

³ The plans shall in­dic­ate the root cause of the iden­ti­fied non-com­pli­ances and shall in­clude a time­frame for im­ple­ment­a­tion of the ac­tions therein.

⁴ Swiss­med­ic shall de­cide wheth­er the pro­posed ac­tion is suit­able and wheth­er the time­frame for im­ple­ment­a­tion is ap­pro­pri­ate.