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

Anonymous · Published March 10, 2026 · 1 comment
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 obligations for legacy devices.

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Anonymous 3 months ago
Some guidance documents are not explicit about UDI requirements for legacy devices.
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Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory ·
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 EUDAMED is not strictly required, but is considered good practice, especially for vigilance purposes. The guidance explains how legacy devices can be registered if desired.

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Anonymous ·
According to MDR Article 123 (f) and (g), UDI labeling is required for Class III devices from May 26, 2021, for Class IIa and IIb devices from May 26, 2023, and for Class I devices from May 26, 2025. However, this applies to MDR devices, not legacy MDD devices.

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Anonymous ·
Legacy devices are exempt from UDI obligations. Also, UDI labeling and UDI registration in EUDAMED are two different requirements. Legacy devices do not have to comply with either as per current guidance.

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

Anonymous · 1 comment
6 months ago
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 dead
Accepted 2 answers

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. Th

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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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How to register MDD devices in EUDAMED and generate EUDAMED ID/DI

Anonymous · 2 comments
5 months ago
Has anyone registered MDD devices in EUDAMED using the EUDAMED ID DI? I have an SRN, but I am unsure if I need a Manufacturer device code to generate the EUDAMED ID and DI, or whether EUDAMED generate
Accepted 1 answer

Yes, I have registered MDD devices in EUDAMED using the EUDAMED ID and DI. If you have the SRN, that's an important step. From my experience, we didn'

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