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    EUDAMED

    European Database on Medical Devices.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    EUDAMED is the IT system established by EU MDR/IVDR for registering devices, economic operators, certificates, clinical investigations, vigilance, and market surveillance information.
    What the regulation says
    The EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) mandate EUDAMED as a central database for various types of medical device and IVD data. Its purpose, as outlined in EU MDR Article 33, is to enhance transparency and coordination of information between Member States and the European Commission. The system facilitates device registration, economic operator registration, vigilance reporting, clinical investigation data management, and market surveillance activities across the EU.

    What this means in practice

    EUDAMED is being rolled out by module. Mandatory use of certain modules begins as each is declared functional.

    Examples

    • A manufacturer registers a new Class IIb medical device in EUDAMED, providing its UDI-DI, basic UDI-DI, and other relevant device characteristics, fulfilling requirements in EU MDR Annex VI, Part A.
    • An Authorized Representative updates its contact information within the EUDAMED economic operator module to ensure compliance with EU MDR Article 11, paragraph 2.
    • Following a serious incident involving a device in the EU, the manufacturer submits a vigilance report to EUDAMED, as required by EU MDR Article 87.
    Common pitfalls
    • •A common misconception is that EUDAMED is a single, fully functional system, when in reality it is being deployed in a modular fashion, with different functionalities becoming mandatory at different times.
    • •Companies often underestimate the data entry burden and the need for accurate, consistent data across all modules, leading to delays in compliance.
    • •Some stakeholders mistakenly believe that EUDAMED replaces national registration requirements entirely, which is not always the case, necessitating careful review of Member State specific guidance.
    • •Failing to establish a robust internal process for EUDAMED data submission and maintenance can result in non-compliance and potential market access issues in the EU.
    • •Assuming that EUDAMED functionality will be static can lead to issues, as the system is subject to ongoing updates and changes, requiring continuous monitoring by economic operators.

    Frequently asked questions

    The mandatory use of EUDAMED modules is staggered. Each module becomes mandatory once it is declared fully functional by the European Commission, and transitional periods may apply, as per the EU MDR implementation timeline.

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    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    European Commission·1RAPS·1FDA·1
    1. 1
      EUDAMED
      Verified
      European Commissionec.europa.eu
    2. 2
      RAPS Regulatory Focus
      Verified
      RAPSraps.org
    3. 3
      FDA - Medical Devices
      Verified
      FDAfda.gov

    Inline markers like [1] jump to the matching reference above.