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

Question

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 referenced in their instructions for use is also missing from EUDAMED. Additionally, I couldn't locate an MDR certificate for the manufacturer.
Is it normal for there to be a delay before devices and their UDIs appear in EUDAMED after manufacturer registration? Are there other reasons why devices or UDIs might not show up?

Dr. Oliver Eidel · Accepted 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 still being rolled out and not all modules are fully functional or mandatory for all actors and devices yet. Sometimes, the manufacturer might have completed registration, but device and UDI submissions are still pending or processing.
Other reasons for missing device or UDI listings can include:
• The manufacturer has not yet submitted the device or UDI data to EUDAMED.
• The device is still under review or awaiting approval in the system.
• Data entry errors or mismatches between instructions for use and EUDAMED records.
• Delays in notifications from Notified Bodies or issues with MDR certification status.

If you need confirmation for regulatory purposes, it's worth reaching out directly to the manufacturer or checking back periodically, as the database is updated over time.

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

1 Answer

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