Medical Devices Ordinance
(MedDO)

¹ Des­ig­nated bod­ies that del­eg­ate part of the work to sub-con­tract­ors or to a sub­si­di­ary bear full re­spons­ib­il­ity for the work car­ried out on their be­half by the sub-con­tract­or or by the sub­si­di­ary.

² They must en­sure that the sub-con­tract­or or the sub­si­di­ary meets the ap­plic­able re­quire­ments of An­nex VII to EU-MDR⁷⁷.

³ They must no­ti­fy Swiss­med­ic if they del­eg­ate work un­der the terms of para­graph 1. They must be able to demon­strate to Swiss­med­ic that the sub-con­tract­or or the sub­si­di­ary is cap­able of car­ry­ing out the tasks as­signed to it.

⁴ Con­form­ity as­sess­ment activ­it­ies may only be del­eg­ated if the des­ig­nated body has in­formed the leg­al or nat­ur­al per­son who re­ques­ted the con­form­ity as­sess­ment ac­cord­ingly.

⁵ The des­ig­nated bod­ies shall make pub­licly avail­able a list of their sub­si­di­ar­ies.