{{RegDocument
| area_of_validity  = EU
| scope             = MD
| document_type     = Regulation – Article Reference
| name              = MDR 2017/745 – Articles 27–29 & Annex VI: Unique Device Identification (UDI)
| version           = 2017/745
| source            = https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745#d1e3455-1-1
| language          = EN, DE, FR
| status            = Current
| restricted_access = No
}}

Articles 27 to 29 and Annex VI of the MDR establish the Unique Device Identification (UDI) system for medical devices placed on the EU market.

== Summary ==

The UDI system enables unambiguous identification and traceability of devices throughout the supply chain and during clinical use.

Key obligations:

* Article 27 – UDI assignment and registration in EUDAMED
* Article 28 – UDI database (part of EUDAMED)
* Article 29 – Registration of devices and economic operators in EUDAMED
* Annex VI Part C – Requirements for the UDI carrier (label placement, symbology)

Application dates vary by device class:
* Class III and implantable: May 2021
* Class IIa and IIb: May 2023
* Class I: May 2025

== Related documents ==

* [[Medical Device Regulation (EU) 2017/745]] – Parent document
* [[IVDR (EU) 2017/746 – Articles 24–26 & Annex VI: UDI]] – Equivalent provision for IVDs

[[Category:Medical Devices]]
[[Category:Labelling]]
[[Category:Traceability]]
