Dezember 31, 2025
Regulatory
EUDAMED's First Four Modules Published
On November 27, 2025, a key milestone was reached in the regulatory landscape for medical devices in the European Union with the official publication of the first four modules of the European Database on Medical Devices (EUDAMED). The European Commission's Decision (EU) 2025/2371, which was published in the Official Journal of the European Union (OJEU), confirmed the functionality and fulfillment of the functional specifications for these modules, signaling a significant development for all stakeholders in the EU medical device sector.
The First Four EUDAMED Modules: An Overview
The modules made available with this publication are crucial to improving transparency, traceability, and market surveillance within the European medical device sector. As part of the Medical Device Regulation (MDR) and In-vitro Diagnostic Medical Device Regulation (IVDR), EUDAMED is designed to facilitate the electronic exchange of information between manufacturers, regulatory authorities, and other stakeholders.
The first four modules are:
1. Actor Registration
This module provides a centralized registration system for all stakeholders involved in the medical device lifecycle. Manufacturers, authorized representatives, importers, and other actors in the supply chain will need to register in the system, allowing for greater oversight and traceability.
2. UDI/Devices Registration
The Unique Device Identification (UDI) system will enable better traceability of devices through their lifecycle. By registering devices and their corresponding UDI data, this module ensures that medical devices can be tracked from production to end-user, significantly enhancing patient safety.
3. Notified Bodies & Certificates
This module facilitates the collection and management of data related to Notified Bodies, including their role in conformity assessments and the issuance of certificates. Transparency in the certification process ensures that only compliant devices are available on the market, promoting safety and regulatory confidence.
4. Market Surveillance
Post-market surveillance is a critical component of ensuring ongoing device safety. This module allows regulatory authorities to monitor and act on potential risks related to medical devices, ensuring that swift action can be taken if issues arise after a device is placed on the market.
A Six-Month Transition Period: What It Means for Stakeholders
The Commission Decision (EU) 2025/2371 also initiates a six-month transition period, as outlined in Regulation (EU) 2024/1860. This transition period gives medical device manufacturers, importers, and other stakeholders time to familiarize themselves with the system and ensure that they are prepared for the mandatory use of these modules by May 28, 2026.
During this time, companies must ensure that they are technically ready to comply with EUDAMED’s requirements. This includes registering their actors, uploading UDI data for their devices, and integrating the Market Surveillance and Notified Bodies & Certificates modules into their regulatory processes. Failing to comply with the deadline could delay market access or result in penalties.
What This Means for the Industry
The publication of these first four modules is a significant step forward for the European Union's goal of creating a comprehensive, transparent, and efficient regulatory framework for medical devices. The system is designed to improve oversight, facilitate faster responses to emerging risks, and streamline the approval and market access process.
With these modules now functional, manufacturers, regulators, and other stakeholders can begin the process of integrating EUDAMED into their everyday operations. This will require investment in new technologies, training for staff, and close collaboration between stakeholders to ensure smooth adoption of the new system.
Looking Ahead: EUDAMED’s Future
While the first four modules are mandatory by May 2026, EUDAMED will continue to evolve with additional modules planned for release in the coming years. These will include modules focused on clinical investigations, vigilance reporting, and more extensive post-market surveillance. The comprehensive data collected across all modules will enable a more holistic approach to device regulation, enhancing both safety and market transparency.
As the system continues to expand, EUDAMED promises to play an integral role in driving innovation, improving patient safety, and ensuring that Europe remains at the forefront of medical device regulation.
Conclusion
The publication of the first four modules of EUDAMED is a critical step in the EU’s journey toward full implementation of the Medical Device Regulation (MDR) and In-vitro Diagnostic Regulation (IVDR). Medical device manufacturers and industry stakeholders now have clear guidance on the regulatory requirements and timelines ahead. As the transition period continues, industry participants must prepare to integrate these modules into their operations, ensuring compliance and maintaining the highest standards of safety and transparency in the market.
With the May 28, 2026 deadline approaching, now is the time for stakeholders to engage with the system and start preparing for a future where EUDAMED plays a central role in medical device regulation across Europe.
Source: European Commission