Medical Devices Ordinance
(MedDO)

¹ Provided they con­tin­ue to com­ply with the old le­gis­la­tion from 26 May 2021 and have not un­der­gone any sig­ni­fic­ant changes in their design or in­ten­ded pur­pose, the fol­low­ing med­ic­al devices may be placed on the mar­ket or put in­to ser­vice un­til 26 May 2024:

a.

devices clas­si­fied as class I un­der the old le­gis­la­tion for which a de­clar­a­tion of con­form­ity was is­sued be­fore 26 May 2021 and for which the con­form­ity as­sess­ment pro­ced­ure un­der this Or­din­ance ne­ces­sit­ates the in­volve­ment of a des­ig­nated body;

b.

devices with a cer­ti­fic­ate val­id un­der Art­icle 100.

² The post-mar­ket sur­veil­lance and mar­ket mon­it­or­ing of these devices, vi­gil­ance, and re­gis­tra­tion of eco­nom­ic op­er­at­ors and of the devices them­selves are sub­ject to the pro­vi­sions of this Or­din­ance.

³ Devices leg­ally placed on the mar­ket pri­or to 26 May 2021 un­der the old le­gis­la­tion and devices placed on the mar­ket from 26 May 2021 un­der para­graph 1 can con­tin­ue to be placed on the mar­ket or put in­to ser­vice un­til 26 May 2025. The above is sub­ject to Art­icle 103.