39 lines
1.4 KiB
Plaintext
39 lines
1.4 KiB
Plaintext
{{RegDocument
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| area_of_validity = EU
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| scope = MD
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| document_type = Regulation – Article Reference
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| name = MDR 2017/745 – Articles 27–29 & Annex VI: Unique Device Identification (UDI)
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| version = 2017/745
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| source = https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745#d1e3455-1-1
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| language = EN, DE, FR
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| status = Current
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| restricted_access = No
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}}
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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.
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== Summary ==
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The UDI system enables unambiguous identification and traceability of devices throughout the supply chain and during clinical use.
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Key obligations:
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* Article 27 – UDI assignment and registration in EUDAMED
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* Article 28 – UDI database (part of EUDAMED)
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* Article 29 – Registration of devices and economic operators in EUDAMED
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* Annex VI Part C – Requirements for the UDI carrier (label placement, symbology)
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Application dates vary by device class:
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* Class III and implantable: May 2021
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* Class IIa and IIb: May 2023
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* Class I: May 2025
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== Related documents ==
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* [[Medical Device Regulation (EU) 2017/745]] – Parent document
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* [[IVDR (EU) 2017/746 – Articles 24–26 & Annex VI: UDI]] – Equivalent provision for IVDs
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[[Category:Medical Devices]]
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[[Category:Labelling]]
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[[Category:Traceability]]
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