Medical Devices Ordinance
(MedDO)

¹ Cus­tom-made devices are sub­ject to the re­quire­ments of An­nex XIII to EU-MDR²⁸. The devices must be ac­com­pan­ied by the state­ment re­ferred to in Sec­tion 1 of An­nex XIII to EU-MDR when they are placed on the mar­ket.

² In ad­di­tion to the pro­ced­ure un­der para­graph 1, man­u­fac­tur­ers of class III im­plant­able cus­tom-made devices must also carry out a con­form­ity as­sess­ment pro­ced­ure as spe­cified in Chapter I of An­nex IX to EU-MDR. Al­tern­at­ively, they may opt for a con­form­ity as­sess­ment in ac­cord­ance with Part A of An­nex XI to EU-MDR.

³ Man­u­fac­tur­ers must draw up, keep up to date and keep avail­able for com­pet­ent au­thor­it­ies the doc­u­ment­a­tion in ac­cord­ance with Sec­tion 2 of An­nex XIII to EU-MDR.