Translated with AI

On November 27, 2025, the European Commission announced the full functionality of four out of the six EUDAMED modules through Commission Implementing Decision (EU) 2025/2371, published in the Official Journal of the European Union.

This decision triggers a six-month transitional period, after which the use of the first four EUDAMED modules becomes mandatory as of 28 May 2026. Economic operators that have not yet made voluntary use of these modules must take action without delay.

The four fully functional EUDAMED modules

The modules declared fully functional and mandatory from 28 May 2026 are:

  1. “Actor Registration” module (ACT)
    This module is intended for the mandatory registration of economic operators, namely manufacturers (including manufacturers of systems and procedure packs), authorised representatives, and importers, in order to obtain a Single Registration Number (SRN). Registration in ACT is a prerequisite for all subsequent activities in EUDAMED, as required under Article 31 of Regulation (EU) 2017/745 (MDR) and Article 28 of Regulation (EU) 2017/746 (IVDR).
  1. “UDI/Devices Registration” module (UDI/DEV)
    This module manages UDI identifiers (UDI-DI and UDI-PI) through a central database for MDR and IVDR devices. It collects detailed device information, including risk class, Basic UDI-DI, and data related to packaging levels and units of use.
    For legacy devices regulated under the MDD or IVDD, as well as custom-made devices or devices for which no individual units are placed on the market after the module becomes mandatory, registration is required only in the context of serious incidents, field safety corrective actions (FSCAs), or vigilance activities. In such cases, EUDAMED-specific DI/ID identifiers are used instead of standard UDI identifiers.
  1. “Notified Bodies and Certificates” module (NB/CRF)
    This module allows Notified Bodies (NBs) to register and manage certificates issued for devices in conformity with the MDR and IVDR. It also collects Summary of Safety and Clinical Performance (SSCP) documents, which are uploaded directly by the Notified Bodies for higher-risk devices.
  1. “Market Surveillance” module (MSU)
    Access to this module is reserved to Competent Authorities and supports the management of post-market surveillance and market surveillance activities, including inspections and the handling of non-compliances.

Priorities for manufacturers

Given the short six-month transition period, manufacturers should focus on the modules under their direct responsibility, namely ACT and UDI/DEV:

  • Priority 1: obtain the Single Registration Number (SRN)
    A critical step: without an SRN, it is not possible to proceed with any EUDAMED registration.
  • Priority 2: prepare UDI data for the UDI/DEV module
    Review and prepare UDI-related data in advance to avoid disruptions to placing devices on the market.

Timelines and derogations for the four modules

The official start date for mandatory use of the four modules is 28 May 2026, and compliance with this deadline should be considered the primary objective in all cases.
However, Regulation (EU) 2024/1860 provides for certain specific temporary derogations, as outlined below.

Manufacturers (UDI/DEV module – UDI & Device Registration)

  • For MDR- and IVDR-compliant devices placed on the market before 28 May 2026, manufacturers benefit from an additional six-month derogation, allowing registration in the UDI/DEV module until 28 November 2026.
  • Exception: the derogation does not apply where devices are involved in vigilance activities (PMSV, MIR, FSCA, or trend reporting), which require immediate registration.

Notified Bodies (NB/CRF module)

  • Notified Bodies benefit from an additional 12-month derogation, until 28 May 2027, to register in the NB/CRF module the certificates issued and the SSCP master copies (for class IIb and class III devices) relating to devices placed on the market before 28 May 2026.
  • Exception: the derogation does not apply in the event of vigilance activities, including serious incidents, PSURs, field safety corrective actions (FSCAs), or other mandatory reporting obligations.

Summary table of deadlines

The mandatory use of EUDAMED modules is not an endpoint, but the starting point for centralized and transparent management of Medical Devices throughout their entire lifecycle.
There is no time to lose. Timely completion of registration in the ACT and UDI/DEV modules is essential to avoid operational disruptions and compliance risks.

For strategic regulatory consultancy, training, and hands-on support in the use of EUDAMED modules, Thema experts are at your side. Contact: sales@complifegroup.com

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