May 2026 EUDAMED Deadline:
Register Today!
Actor & UDI/Device registrations on EUDAMED becomes mandatory on the May 28, 2026 deadline. Take action today.
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Brussels, 1200, Belgium
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How Obelis Can Help You
Don't risk non-compliance! The EUDAMED deadline is approaching fast
Frequently Asked Questions
What is EUDAMED and why is it important?
EUDAMED is the central EU database for medical devices an operators under MDR/IVDR. It serves as a central platform to enhance transparency, traceability, and post-market surveillance of medical devices across the EU.
Who is responsible for registering in EUDAMED?
Manufacturers, authorised representatives, importers, system and procedure pack producers involved in placing medical devices or IVDs on the EU market are responsible for registering their organisation and devices in EUDAMED.
What if my device is already on the market?
Devices placed on the market before 28 May 2026 and not sold after that date do not require registration, unless post-market surveillance actions occur. Devices places on the market before 28 May 2026 and continuing to be sold after that date must be registeres, with a transition period until 28 November 2026. Devices placed on the market the first time after 28 May 2026 must be registered before being placed on the market, with no transitional period.
What happens if I don't meet the EUDAMED deadline?
Failure to complete your EUDAMED registration by the legally mandated deadline constitutes non-comliance with EU regulatory requirements. Devices that are not duly registered, or whose information is missing or incomplete, cannot be legally placed on the EU market. Competent authorities and distributors are legally required to refuse market access to non-compliant devices.
How can Obelis assist with EUDAMED registration?
Obelis supports EU and non-EU manufacturers and other economic operators by managing actor registration, obtaining Single Registration Numbers (SRN), uploading device data, and ensuring full compliance with MDR and IVDR requirements. Our Brussels location and regulatory expertise help fast-track validation and smooth communication with Competent Authorities.
Learn More About EUDAMED & Your Next Compliance Steps
Watch our expert webinar and understand what the 2026 mandatory deadline means for your device.
EUDAMED Compliance Roadmap
