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Are distributors required to register in EUDAMED under MDR?

Anonymous · Published February 14, 2026 · 1 comment
We are reviewing the requirements for economic operators and their registration in EUDAMED. Specifically, do distributors (as defined in MDR Article 14) have to register in EUDAMED?
According to MDR Article 30, only manufacturers, importers, and authorized representatives are mentioned, but not distributors. Additionally, when using EUDAMED in the economic operator section, there is no option to register distributors.

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Anonymous 4 months ago
It seems like EUDAMED does not currently support distributor registration, but I would appreciate confirmation from others who have experience with this process.
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Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory ·
Distributors don't need to register in EUDAMED. Only manufacturers, importers, and authorized representatives are required to register. The system currently does not have a registration option for distributors.

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