Medical Devices Ordinance
(MedDO)

¹ Cus­tom-made devices are sub­ject to the re­quire­ments of An­nex XIII to EU-MDR¹⁶. The de­clar­a­tion ac­cord­ing to Sec­tion 1 of An­nex XIII to EU-MDR must be en­closed when the devices are placed on the mar­ket.

² In ad­di­tion to the pro­ced­ure un­der para­graph 1, man­u­fac­tur­ers of class III im­plant­able cus­tom-made devices must also con­duct 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 cre­ate and up­date the doc­u­ment­a­tion spe­cified in Sec­tion 2 of An­nex XIII to EU-MDR and en­sure it can be made avail­able to the com­pet­ent au­thor­it­ies.