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EUDAMED: Upcoming Obligations for Medical Device Manufacturers

Medical devices regulation

On 21 May 2025, the European Commission held a workshop in Stuttgart to provide an update on the deployment of EUDAMED, the European database on medical devices. This article summarises the key information to remember, including upcoming deadlines, registration rules, and what manufacturers, authorised representatives, importers, and notified bodies need to prepare for.



EUDAMED: Regulatory Background and Legal Framework

EUDAMED is part of the regulatory framework established by Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). The recently published Regulation (EU) 2024/1860 introduces a phased deployment of the database. Each module can become mandatory once audited and declared functional—no need to wait for the entire system to be completed. The six EUDAMED modules are:

  • Economic Operators (SRN)
  • UDI/Devices
  • Certificates / Notified Bodies
  • Vigilance
  • Clinical Investigations / Performance Studies
  • Market Surveillance



Phased Rollout and Expected Timeline

According to the current roadmap, the Commission expects to publish the first notices of functionality in the Official Journal of the EU (OJEU) in July 2025, triggering a 6-month transition period before mandatory use. The first four modules concerned are:

  • Economic Operators
  • UDI/Devices
  • Certificates / CRF
  • Market Surveillance

As a result, these modules are expected to become mandatory from January 2026.



What Manufacturers Need to Do

1. Register as an Economic Operator

Manufacturers, authorised representatives, importers, and system/procedure pack producers must obtain their Single Registration Number (SRN) now through the “Actors” module in EUDAMED.



2. Register Devices in the UDI/DEV Module

  • For MDR/IVDR devices: registration is mandatory before placing the first unit on the EU market, after the module becomes active.
  • For legacy devices: registration is required within 12 months if additional units are placed on the market after that date.
  • No duplicate registration is needed if a legacy device is identical to a device already registered under MDR (same UDI-DI or reference).



3. Register Certificates

  • Certificates issued after the module becomes mandatory must be registered immediately.
  • Certificates issued before must be registered within 18 months of the module’s functionality notice publication.

⚠️ Note: Only the latest certificate version and NB decision should be submitted.



Training and Support Coming Soon

The European Commission has announced several training sessions:

  • June 2025: Actors and UDI/Devices modules
  • September 2025: Certificates and Market Surveillance modules
  • Upcoming hybrid workshops:
    • Rome – 8 October 2025
    • Brussels – 3 December 2025

Video tutorials and learning materials will also be available through the EUDAMED Information Centre.



Useful Resources


Related Articles

Explore other useful resources on EUDAMED and regulatory compliance:




❓ Mini EUDAMED FAQ

When will EUDAMED become mandatory?

From January 2026 for the first four modules, assuming the OJEU notice is published in July 2025.



Do I have to register my legacy devices?

Yes, if additional units are placed on the market after the UDI/DEV module becomes mandatory. You have 12 months to do so.



Which certificates need to be registered?

All MDR/IVDR certificates, depending on their issuance date—either immediately or within 18 months.



Conclusion

EUDAMED is finally moving forward, module by module. Now is the time to shift from passive monitoring to action. Early registration in the Actors module, alignment with your Notified Body for certificates, and UDI data readiness should be top priorities.



Need help?

At CSDmed, we support medical device manufacturers with end-to-end compliance, from classification to full registration in EUDAMED. Reach out to us for a review of your nomenclature and get ahead of upcoming regulatory shifts.



Written by Guillaume Valenzuela – part of the CSDmed team.

Link to the Presentation