Do distributors need to register in EUDAMED under MDR?

Anonymous · Published February 23, 2026 · 1 comment

I am seeking clarification regarding the registration requirements for economic operators in EUDAMED under the Medical Device Regulation (MDR).

Specifically, do distributors (as defined in MDR Article 14) have to register in EUDAMED? Article 30 of the MDR only mentions manufacturers, importers, and authorized representatives for registration, and the EUDAMED economic operator section does not appear to offer an option for distributor registration.

Can anyone confirm if distributors are required to register, or provide guidance on this point?

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Anonymous 4 months ago

This question has come up before; clarification would be helpful for many economic operators.

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Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory · 4 months ago

Distributors do not need to register in EUDAMED. Only manufacturers, importers, and authorized representatives are required to register according to Article 30 of the MDR. This is also reflected in the EUDAMED system, where there is currently no option for distributor registration.

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