EU Commission Announces Four EUDAMED Modules as Fully Functional -MDR/IVDR Transition Periods Officially Begin

On 26 November 2025, the European Commission published Commission Decision (EU) 2025/2371, officially confirming that four key modules of EUDAMED are now fully functional. This announcement triggers the start of the transition periods for certain obligations under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).

This decision directly influences the operational responsibilities of manufacturers, authorised representatives, importers, distributors, and notified bodies.

Which Modules Have Been Declared Functional?

Following an independent audit conducted in June 2025, the Commission confirmed that the following EUDAMED modules meet the functional specifications:

  1. Economic Operator Registration (Actors Module)
    MDR Article 30, IVDR Article 27
    Manufacturer / Authorised Representative / Importer / System & Procedure Pack Producer
  2. UDI Database & Device Registration Module (UDI & Devices)
    MDR Articles 28–29
    Basic UDI-DI management, UDI-DI assignment and device registration
  3. Notified Bodies and Certificates Module
    MDR Article 57
    CE certificates, scope, status, validity timelines
  4. Market Surveillance Module
    MDR Article 100
    Communication and coordination between competent authorities

What Does This Decision Mean?

With the publication of this decision:

  • The transition periods for the related MDR/IVDR obligations officially begin.
    (Reference: MDR Article 123(3), IVDR Article 113(3))
  • The modules are now moving from “voluntary use” to mandatory use within the defined timelines.
  • Manufacturers must complete their EUDAMED readiness processes without delay.

Implications for Economic Operators

Manufacturers (MDR/IVDR):
Completion of EUDAMED actor registration
Registration of Basic UDI-DI and UDI-DI device data
Data readiness for full device portfolio, including legacy devices
Certificate data managed by Notified Bodies in the system

Authorised Representatives:
Verification of manufacturer mandates
Management of access rights within EUDAMED

Importers / Distributors:
Ensuring supply-chain checks are aligned with EUDAMED actor registration
Strengthening traceability processes using UDI information

Notified Bodies:
Mandatory electronic submission of CE certificates
Updates on certificate changes, reductions, suspensions, withdrawals

Expected Impact

Increased transparency
Public access to device, manufacturer, and certificate information will progressively expand.

Accelerated market surveillance
Information exchange between EU authorities will become more efficient and automated.

Compliance pressure on manufacturers
Failure to prepare for EUDAMED requirements may result in:

•    Nonconformities during NB audits
•    Observations or warnings from competent authorities
•    Delays in placing devices on the EU market

Conclusion
This decision confirms that essential EUDAMED components are now operational, marking a significant milestone in the digital transformation of the EU medical device regulatory framework. All economic operators should proactively prepare their data, UDI structures and registration workflows to ensure timely compliance with upcoming mandatory requirements.