Medical Devices Ordinance
(MedDO)

¹ Man­u­fac­tur­ers of devices made avail­able in Switzer­land or nat­ur­al or leg­al per­sons who as­semble sys­tems or pro­ced­ure packs in ac­cord­ance with Art­icle 22 para­graphs 1 and 3 EU-MDR¹⁰⁶ must re­port to Swiss­med­ic:

a.

any ser­i­ous in­cid­ents in­volving the device in ques­tion that have oc­curred in Switzer­land, as soon as they be­come aware of them;

b.

any field safety cor­rect­ive ac­tions un­der­taken in Switzer­land.¹⁰⁷

² Ex­emp­tions from this re­port­ing ob­lig­a­tion, mod­al­it­ies, peri­od­ic sum­mary re­ports, trend re­port­ing and ana­lyses of ser­i­ous in­cid­ents and field safety cor­rect­ive ac­tions are gov­erned by Art­icles 27 para­graph 5 and 87–89 EU-MDR.

^2bis Where an au­thor­ised rep­res­ent­at­ive is re­quired pur­su­ant to Art­icle 51, this rep­res­ent­at­ive is re­spons­ible for the re­port­ing ob­lig­a­tion in para­graph 1. Fur­ther­more, the au­thor­ised rep­res­ent­at­ive must sub­mit the trend re­ports pur­su­ant to para­graph 2 on in­cid­ents in Switzer­land and abroad to Swiss­med­ic without be­ing re­ques­ted to do so. Fi­nal re­ports pre­pared in ac­cord­ance with Art­icle 89 para­graph 5 EU-MDR should be sub­mit­ted to Swiss­med­ic. The trans­fer of these ob­lig­a­tions from the man­u­fac­turer or from the nat­ur­al or leg­al per­son as­sem­bling sys­tems or pro­ced­ure packs un­der Art­icle 22 para­graphs 1 and 3 EU-MDR to the au­thor­ised rep­res­ent­at­ive must be agreed in writ­ing in the man­date.¹⁰⁸

³ ...¹⁰⁹

⁴ Any pro­fes­sion­al who be­comes aware of a ser­i­ous in­cid­ent when us­ing devices must re­port this to the sup­pli­er and Swiss­med­ic. The re­port may be sub­mit­ted by a pro­fes­sion­al as­so­ci­ation. The timelines for do­ing so are as set out in Art­icle 87 EU-MDR.

⁵ Re­ports must be sub­mit­ted to Swiss­med­ic elec­tron­ic­ally and in ma­chine-read­able format. Swiss­med­ic pub­lishes in­form­a­tion on elec­tron­ic sub­mis­sion and the forms to be used with con­tent spe­cific­a­tions.