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

This decision initiates a 6-month transition period, after which the use of the first four modules will become mandatory from May 28, 2026. Economic operators that have not yet used these modules on a voluntary basis should act as soon as possible.

The four functional EUDAMED modules

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

Actor Registration Module (ACT)

This module enables the mandatory registration of economic operators, namely manufacturers (including system and procedure pack producers), authorised representatives, and importers, in order to obtain the Single Registration Number (SRN).

This registration is mandatory and preliminary for all subsequent operations within EUDAMED, as established by Article 31 of the Regulation (EU) 2017/745 and Article 28 of the Regulation (EU) 2017/746.

UDI/Devices Registration Module (UDI/DEV)

This module manages UDI identifiers (UDI-DI/UDI-PI) through a central database for devices regulated under MDR and IVDR.

It collects detailed device information, including:

• risk class

• Basic UDI

• packaging levels and units of sale

For legacy devices (MDD/IVDD) and other regulated products—such as custom-made devices or devices for which individual units are no longer placed on the market after the module becomes mandatory—registration is required only in cases of serious incidents, field safety corrective actions (FSCA), or vigilance activities. In such cases, specific EUDAMED DI/ID identifiers are used instead of standard UDIs.

Notified Bodies and Certificates Module (NB/CRF)

This module allows Notified Bodies to register and manage certificates issued for devices compliant with MDR and IVDR.

It also collects Summaries of Safety and Clinical Performance (SSCP), which are submitted directly by Notified Bodies for higher-risk devices.

Market Surveillance Module (MSU)

Access to this module is reserved for Competent Authorities, enabling them to manage post-market surveillance and market surveillance activities, including inspections and the handling of non-compliance cases.

Priorities for manufacturers

With a transition period of only six months, manufacturers should focus primarily on the ACT and UDI/DEV modules, which fall under their direct responsibility.

Priority 1: Obtain the Single Registration Number (SRN)
This is the most critical step, as no registrations can proceed without the SRN.

Priority 2: Prepare UDI data for the UDI/DEV module
Manufacturers should review and prepare UDI code details to avoid delays or barriers when placing devices on the market.

Timelines and derogations for the four modules

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

• Devices compliant with MDR and IVDR placed on the market before May 28, 2026 benefit from an additional 6-month derogation, allowing registration in the UDI/DEV module until November 28, 2026.

• Exception: this derogation does not apply if the device is involved in vigilance activities such as PMSV, MIR, FSCA, or trend reporting, which require immediate registration.

Notified Bodies (NB/CRF Module)

• Notified Bodies benefit from an additional 12-month derogation, allowing them to register certificates and Master SSCPs (for Class IIb and III devices) issued for devices placed on the market before May 28, 2026 until May 28, 2027.

• Exception: the derogation does not apply in cases involving vigilance actions, such as serious incidents, PSUR submissions, FSCA, or mandatory reporting obligations.

A new phase for device lifecycle management

The mandatory use of EUDAMED modules should not be seen as the final goal, but rather as the starting point for centralized and transparent device management throughout the entire lifecycle.

There is little time left to prepare. It is essential to complete registration in the ACTOR and UDI/DEV modules as soon as possible to avoid operational disruptions and compliance risks.

For strategic regulatory consulting, training, and hands-on support in using EUDAMED modules, Complife experts are available to assist you.

Contact: sales@complifegroup.com

Sources

• Commission Decision (EU) 2025/2371 – EUR-Lex

• Regulation (EU) 2024/1860 – EUR-Lex

• EUDAMED – European Commission Public Health Portal