Medical Devices Ordinance
(MedDO)

¹ If the man­u­fac­turer is dom­i­ciled in an EU or EEA state or if the man­u­fac­turer has des­ig­nated an au­thor­ised rep­res­ent­at­ive dom­i­ciled in an EU or EEA state, that man­u­fac­turer must, for all devices placed on the mar­ket after 26 May 2021, des­ig­nate an au­thor­ised rep­res­ent­at­ive in ac­cord­ance with Art­icle 51 para­graph 1 with­in the fol­low­ing time peri­ods:

a.

for class III devices, class IIb im­plant­able devices and act­ive im­plant­able devices: by 31 Decem­ber 2021;

b.

for non-im­plant­able class IIb devices and class IIa devices: by 31 March 2022;

c.

for class I devices: by 31 Ju­ly 2022.

² For sys­tems and pro­ced­ure packs, an au­thor­ised rep­res­ent­at­ive in ac­cord­ance with Art­icle 51 para­graph 5 must be ap­poin­ted by 31 Ju­ly 2022.