EUDAMED Roll-Out: New Q&A Document Under MDR and IVDR

A Q&A document was published outlining the practical aspects of the gradual roll-out of EUDAMED pursuant to the MDR and IVDR (as amended by Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746). The document contains Q&A for clarification of each module in EUDAMED, providing clear instructions on the obligations of users and potential users of the database. 

EUDAMED Q&A Document Key Takeaways: 

• • Article 34 MDR amended by Regulation 2024/1860 allows gradual roll-out of EUDAMED: MDCG will be informed when the functionality of a module following independent audit (s). This phased approach aims to ensure a smoother implementation and transition for stakeholders.
  • Transition periods for mandatory use of Actor: UDI/DEV modules is 6 months after the publication in the OJEU of the notice confirming that the module(s) is functional.
  • Explanation of how to register as an Actor in the Actor Module which is now voluntary in EUDAMED: It is recommended for manufacturers, importers, authorized representatives and SPPP’s to register without delay.
  • Clarification of the mandatory use of UDI/DEV module for legacy devices and MDR approved devices: Custom-made devices, investigational devices and devices for performance studies are exempt from registration in the UDI/DEV module. It is advised to register devices and SPP’s as soon as possible.
  • The Vigilance module will be released when it becomes mandatory and must be used straight away: Manufacturers and Authorized representatives will be required to submit PSUR’s and vigilance reports in EUDAMED as soon as the module is available with no voluntary use or transitional timeline. 

As a Manufacturer, What Should I Do Now? 

• • Register in EUDAMED and obtain the Single Registration Number (SRN). 

• • Register applicable devices in the UDI/DEV module.

• • Continue to report Vigilance according to MDCG 2021-Rev.1 and MDCG 2022-12.

• • Check MDCG and OJEU for updates on transitional timelines and mandatory use of the individual modules. 

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With the gradual roll-out of EUDAMED, manufacturers and other stakeholders must stay proactive and informed. If you need guidance or support during this process, don’t hesitate to contact us for expert assistance.

Learn how MedEnvoy can assist you:

• • • EU Authorized Representative
    • EU Regulatory Importer
    • EUDAMED Registration Management