Medical Devices Ordinance
(MedDO)

¹ Where the man­u­fac­turer of a device is not dom­i­ciled in Switzer­land, the device may only be placed on the mar­ket if the man­u­fac­turer des­ig­nates an au­thor­ised rep­res­ent­at­ive dom­i­ciled in Switzer­land by means of a writ­ten man­date.

² The au­thor­ised rep­res­ent­at­ive is re­spons­ible for the form­al and safety-re­lated as­pects of pla­cing the device on the mar­ket.

³ The au­thor­ised rep­res­ent­at­ive’s rights and ob­lig­a­tions and the scope of its man­date are gov­erned by Art­icle 11 EU-MDR⁸⁸.

^3bis The man­u­fac­turer and au­thor­ised rep­res­ent­at­ive may con­trac­tu­ally agree that in­stead of the au­thor­ised rep­res­ent­at­ive keep­ing avail­able a copy of the tech­nic­al doc­u­ment­a­tion, the man­u­fac­turer shall, on re­quest, sub­mit the doc­u­ment­a­tion straight to Swiss­med­ic. The au­thor­ised rep­res­ent­at­ive must en­sure that the doc­u­ment­a­tion is sub­mit­ted with­in sev­en days.⁸⁹

⁴ Changes in au­thor­ised rep­res­ent­at­ive are gov­erned by Art­icle 12 EU-MDR.

⁵ Para­graphs 1–4 also ap­ply mu­tatis mutandis to nat­ur­al or leg­al per­sons who as­semble sys­tems and pro­ced­ure packs in ac­cord­ance with Art­icle 22 para­graphs 1 and 3 EU-MDR and who are not dom­i­ciled in Switzer­land.⁹⁰