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.
Reach out to us to discuss your specific questions, avoid costly mistakes, and ensure your registrations are done right the first time.
