Medical Devices Ordinance
(MedDO)


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Art. 17 Unique device identification

1 Any man­u­fac­turer or any nat­ur­al or leg­al per­son who as­sembles sys­tems and pro­ced­ure packs in ac­cord­ance with Art­icle 22 para­graphs 1 and 3 EU-MDR41 shall as­sign to the device, sys­tem or pro­ced­ure pack, with the ex­cep­tion of cus­tom-made devices, and all high­er levels of pack­aging a unique device iden­ti­fi­er (UDI42) pri­or to pla­cing it on the mar­ket.43

2 It must state the UDI on the la­belling of the device, sys­tem or pro­ced­ure pack and all high­er levels of pack­aging. Ship­ping con­tain­ers are not con­sidered as a high­er level of pack­aging.44

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.45

4 The ob­lig­a­tions and mod­al­it­ies as­so­ci­ated with device iden­ti­fic­a­tion and re­gis­tra­tion are gov­erned by Art­icles 27 and 29 and An­nex VI to EU-MDR, tak­ing ac­count of the amend­ments to this An­nex ad­op­ted by the European Com­mis­sion by means of del­eg­ated acts46.

5 ...47

41 See the foot­note to Art. 4 para. 1 let. f.

42 Stands for «Unique Device Iden­ti­fic­a­tion»

43 Amended by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281).

44 Amended by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281).

45 Amended by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281).

46 See An­nex 4.

47 Enters in­to force at a later date (Art. 110 para. 2).

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