Medical Devices Ordinance
(MedDO)

¹ Any man­u­fac­turer or nat­ur­al or leg­al per­son who as­sembles sys­tems and pro­ced­ure packs in ac­cord­ance with Art­icle 22 para­graphs 1 and 3 EU-MDR²⁴ shall as­sign the product, sys­tem or pro­ced­ure pack, with the ex­cep­tion of cus­tom-made devices, and all su­per­or­din­ate pack­aging lay­ers a unique device iden­ti­fi­er (UDI²⁵) pri­or to pla­cing it on the mar­ket.²⁶

² It must state the UDI on the la­belling of the device, sys­tem or pro­ced­ure pack and all su­per­or­din­ate pack­aging lay­ers. Trans­port con­tain­ers are not re­garded as a su­per­or­din­ate pack­aging lay­er.²⁷

³ It shall main­tain a list of all the UDIs it has as­signed. This list is part of the tech­nic­al doc­u­ment­a­tion spe­cified in An­nex II to EU-MDR. It must be kept up-to-date at all times.²⁸

⁴ The ob­lig­a­tions and mod­al­it­ies as­so­ci­ated with product iden­ti­fic­a­tion and re­gis­tra­tion are gov­erned by Art­icles 27 and 29 and An­nex VI to EU-MDR, tak­ing ac­count of the amend­ments to this An­nex made by the European Com­mis­sion by means of del­eg­ated acts²⁹.

⁵ ...³⁰