EUDAMED advice for free! We bust EUDAMED myths 💡

Numerous misunderstandings exist around EUDAMED. We are happy to share and clarify them for you!
Exemptions and further aspects may apply.

Myth #1: The EUDAMED registration obligation applies only to MDR/IVDR compliant devices
✅ Truth: The registration obligations apply to both Regulation as well as “legacy” devices. Registration of legacy devices can be skipped only if the Regulation “pendants” are already registered.

Myth #2: Many devices can be grouped under one registration
✅ Truth: Every device (at the level of UDI-DI/catalogue number/reference number) must be registered. Especially here it is worth checking the exemptions stipulated in the Regulations. Make the count!

Myth #3: The registrations are not visible to the public
✅ Truth: Most of registered information about the company, the devices and other aspects is publicly visible: every lay person can access it. Importers (your customers?) must check that devices are registered and may reach out if they are not.

Myth #4: The xml upload is easily done
✅ Truth: EUDAMED is very picky when it comes to the compatibility of xml files. Teams already have underestimated the effort and skills required to establish a working solution and lost valuable time.

Myth #5: All information that is asked for during the verification is mandatory to submit
✅ Truth: Watch out for the red asterisk! If not indicated, the information often is optional (especially here, exemptions apply).

Myth #6: After registration the information can be easily corrected
✅ Truth: Most information is locked after submission. “Correction” is only possible by discarding the registration (only possible if it has not been linked to another EUDAMED element) and re-registration.

Myth #7: EUDAMED is a one-time job
✅ Truth: The Regulations stipulate that the registrations must be kept up-to-date.

Myth #8: You are alone with the EUDAMED obligation
✅ Truth: You are not! We can discuss any question you may have, train your team and can do the registration on your behalf. Contact details in the comments.