40 lines
1.5 KiB
Plaintext
40 lines
1.5 KiB
Plaintext
{{RegDocument
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| area_of_validity = EU
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| scope = IVD
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| document_type = Regulation – Article Reference
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| name = IVDR (EU) 2017/746 – Articles 24–26 & Annex VI: UDI
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| version = 2017/746
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| source = https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746#d1e3362-1-1
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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 24 to 26 and Annex VI of the IVDR establish the Unique Device Identification (UDI) system for IVDs placed on the EU market. The framework is aligned with the MDR UDI system.
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== Summary ==
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The UDI system enables unambiguous identification and traceability of IVDs throughout the supply chain and in clinical laboratories.
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Key obligations:
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* Article 24 – UDI assignment and registration in EUDAMED
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* Article 25 – UDI database (part of EUDAMED)
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* Article 26 – 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 by device class:
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* Class D: May 2022
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* Class C: May 2023
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* Class B and A (sterile): May 2025
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* Class A (non-sterile): May 2027
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== Related documents ==
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* [[In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746]] – Parent document
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* [[MDR 2017/745 – Articles 27–29 & Annex VI: Unique Device Identification (UDI)]] – Equivalent provision for medical devices
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[[Category:In Vitro Diagnostics]]
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[[Category:Labelling]]
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[[Category:Traceability]]
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