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Is UDI required for Class I devices under MDR before May 2025?

Anonymous · Published December 27, 2025 · 1 comment
Is it necessary to have a UDI (Unique Device Identification) for Class I medical devices under the EU MDR before May 2025? I have seen conflicting information, with some sources indicating a 2024 deadline. I would appreciate clarification and any official references.

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Anonymous 6 months ago
Some legal experts may interpret the requirement differently depending on whether you mean UDI assignment or UDI carrier application.
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Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory ·
I was looking into this for my own product and found that for Class I devices, the UDI carrier does not need to be on the device until 26 May 2025. This is stated in the official FAQ from the European Commission and also on the UDI Helpdesk site: If someone is saying you need it earlier, it might be worth asking what specific requirement they mean.

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Anonymous ·
There is a difference between UDI assignment (such as Basic-UDI, UDI-DI, and UDI-PI), which should be included in your technical documentation, and the requirement to apply the UDI carrier to the device itself. MDR-compliant devices need UDI assignment now, but the physical carrier deadline depends on the risk class. For Class I, the deadline for the UDI carrier is 26 May 2025.

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UDI and EUDAMED Requirements for Legacy MDD Devices as of May 2023

Anonymous · 1 comment
3 months ago
Do legacy MDD devices need a UDI and/or to be registered in EUDAMED since May 2023, or has this requirement been postponed? There seems to be confusion regarding UDI labeling and registration obligati
Accepted 3 answers

The MDR is not explicit in requiring legacy devices to be subject to UDI obligations. According to MDCG 2019-5, registration of legacy devices in EUDA

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Why are some devices and UDIs not listed on EUDAMED despite manufacturer registration?

Anonymous · 1 comment
4 months ago
I noticed that although a manufacturer is listed in EUDAMED, they do not have any devices appearing under their profile. Specifically, I could not find devices for this manufacturer, and the UDI-DI re
Accepted 1 answer

Yes, it is quite common for there to be delays before devices and UDIs appear in EUDAMED, even if the manufacturer is already registered. EUDAMED is s

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