Normiq
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MDR Art. 27

Unique Device Identification system (UDI)

Assignment of the Basic UDI-DI, the UDI-DI and the UDI-PI, and placing of the carrier on the label

Category
Founding texts
Market
European Union
Applicable classes
Class I medical device, Class IIa medical device, Class IIb medical device, Class III medical device
Applicable since
May 26, 2021

In practice

Placing the UDI carrier on the label and on all higher levels of packaging came into application in stages (Article 123(3)(f)): implantable and class III devices since 26 May 2021, classes IIa and IIb since 26 May 2023, class I since 26 May 2025. For reusable devices that must carry the UDI on the device itself, the obligation applies two years after the date for their class.

Official sources

https://eur-lex.europa.eu/eli/reg/2017/745/oj/fra

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