Explore the EUDAMED modules under EU MDR and IVDR, their purpose, upcoming deadlines, and how structured data and traceability affect medical device compliance across the EU.
Introduction to EUDAMED
The European Database on Medical Devices (EUDAMED) is the European Union’s centralized digital platform for collecting, managing, and sharing regulatory information related to medical devices and in vitro diagnostic devices. It was developed by the European Commission to improve transparency, strengthen patient safety, and harmonize regulatory oversight across EU member states.
Under the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746), manufacturers and other economic operators face expanded obligations related to traceability, clinical evidence, and post-market surveillance.
EUDAMED serves as the digital foundation that enables organizations to meet these requirements through standardized, structured reporting. Although some modules were initially available on a voluntary basis, EUDAMED is transitioning toward mandatory use.
As individual modules become fully functional and validated, companies must migrate away from national systems and rely on EUDAMED as the primary regulatory database for EU market access. Watch our recent webinar to learn more.
Overview of the EUDAMED Modules
EUDAMED is composed of six interconnected modules that together support end-to-end regulatory compliance. Each module addresses a specific stage of the medical device lifecycle while contributing to a unified compliance ecosystem.
The six core modules include:
- Actor Registration Module: Registers manufacturers, authorized representatives, importers, and other economic operators and assigns a Single Registration Number (SRN).
- UDI and Device Registration Module: Stores Unique Device Identification (UDI) data and core product information to support traceability.
- Notified Bodies and Certificates Module: Publishes notified body designations and issued certificates for verification purposes.
- Clinical Investigations and Performance Studies Module: Manages submissions and reporting for clinical and performance studies.
- Vigilance and Post-Market Surveillance Module: Centralizes serious incident reports, field safety corrective actions, and trend reports.
- Market Surveillance Module: Enables competent authorities to share enforcement and inspection information.
Together, these modules provide regulators and manufacturers with a comprehensive view of device compliance across the EU.
Purpose and Function of Each Module
Each EUDAMED module plays a distinct role in supporting regulatory transparency, accountability, and efficiency. Rather than operating independently, the modules are designed to work together, allowing authorities and manufacturers to monitor devices throughout their lifecycle.
At the foundation, the Actor Registration and UDI modules establish clear links between economic operators and their products. This connection enables rapid identification of responsible parties and affected devices in the event of recalls or safety concerns.
The Notified Bodies and Certificates Module enhances confidence in conformity assessments by making certification data more accessible and verifiable. This reduces administrative burden and supports consistent enforcement.
Clinical and performance study information contributes to evidence-based regulatory decision-making. Centralizing this data helps authorities assess safety and performance more effectively and identify emerging risks earlier.
Vigilance and market surveillance modules capture real-world performance data and regulatory actions. When combined with registration and certification data, these modules provide a holistic view of compliance, risk, and market performance.
Key Deadlines and Transition Periods
EUDAMED is being implemented through a phased rollout process. Each module becomes mandatory only after it is formally declared fully functional by the European Commission and published in the Official Journal of the European Union.
In general, organizations are expected to transition to mandatory use within six months of a module’s validation. During this period, alternative national systems may still be permitted, but these transitional arrangements are temporary.
Regulatory teams should closely monitor official communications to stay informed about evolving timelines.
Key considerations include:
- Monitoring functional status declarations for each module
- Preparing internal systems before mandatory use
- Aligning submission schedules with new reporting requirements
- Training relevant teams on updated workflows
EUDAMED Rollout at a Glance for Manufacturers
The EUDAMED rollout introduces new registration requirements tied to when a device is placed on the EU market. The key distinction is whether a device is placed on the market before or after the date of mandatory use. Understanding which scenario applies is essential for meeting registration deadlines and avoiding compliance gaps.
To date, four EUDAMED modules have been declared functional: Actor Registration, UDI and Device Registration, Notified Bodies and Certificates, and Market Surveillance. While not all of these modules impose immediate obligations on manufacturers, their availability represents a major step toward full EUDAMED implementation.
Additional modules, including Vigilance and Clinical Investigations and Performance Studies, remain under development and will follow a separate rollout timeline.
EUDAMED Timeline and Deadlines
This timeline focuses on EUDAMED modules that introduce phased, time-bound obligations for manufacturers, particularly those tied to device registration and structured data submission.
Actor Registration is not shown because it is already mandatory and does not follow a future transition or rollout schedule. The Market Surveillance module is also excluded, as it primarily supports competent authority activities and does not currently impose new, deadline-driven requirements on manufacturers.
| Date | What Happens | What Manufacturers Need to Do |
|---|---|---|
| November 27, 2025 | EUDAMED UDI/DEV and NB & Certificates modules announced as functional | Begin preparation and data validation |
| May 28, 2026 | Mandatory use of UDI/DEV and NB & Certificates modules | New Regulation devices must be registered before being placed on the EU market |
| From May 28, 2026 | New devices placed on the market | Register devices in EUDAMED at the UDI-DI level before first placement |
| By November 28, 2026 | Registration deadline for legacy devices | Register legacy devices still on the market in the UDI/DEV module |
Manufacturers should confirm whether devices fall under the “new” or “legacy” category, validate UDI-DI data early, and plan EUDAMED registrations ahead of the mandatory use date to avoid delays in EU market access.
Failure to meet EUDAMED deadlines or submit complete data can result in certificate validation issues, delayed market access, increased regulatory scrutiny, and potential findings of non-compliance.
Implications for Manufacturers and Regulatory Teams
One of the most significant impacts of EUDAMED is its emphasis on structured, standardized data. Unlike traditional document-based submissions, EUDAMED relies on defined data fields and controlled formats, requiring organizations to rethink how regulatory information is managed.
High-quality structured data supports:
- Faster and more predictable submissions
- Improved device and certificate traceability
- Reduced duplication of regulatory information
- More efficient change and variation management
To achieve these benefits, organizations must align processes across regulatory affairs, quality, clinical, IT, and supply chain functions. Clear data ownership, standardized naming conventions, and strong governance frameworks are essential.
Many companies encounter challenges during EUDAMED implementation, including inconsistent legacy data, limited internal resources, and heavy reliance on manual entry. These issues can slow submissions and increase the risk of errors.
Early investment in data harmonization and digital infrastructure can significantly improve long-term compliance outcomes.
Integrating EUDAMED Compliance Into RIM
Regulatory Information Management (RIM) systems play a critical role in enabling sustainable EUDAMED compliance. A modern RIM platform provides a centralized repository for regulatory and product data, serving as a single source of truth across the organization.
When integrated with EUDAMED workflows, RIM systems help teams:
- Centralize actor, device, and certificate information
- Maintain version control and audit trails
- Track submission readiness and deadlines
- Validate data prior to reporting
- Coordinate internal reviews and approvals
Automation further strengthens compliance efforts. Automated checks can identify missing or inconsistent data before submission, reducing the likelihood of rejection or follow-up requests. Workflow tools improve cross-functional collaboration and support consistent execution.
Over time, RIM-enabled compliance shifts organizations from reactive problem-solving to continuous regulatory readiness.
Conclusion
Understanding the structure, purpose, and timelines of the EUDAMED modules is essential for maintaining EU market access under MDR and IVDR. As regulatory data becomes more interconnected and transparent, manufacturers must adapt their systems and processes accordingly.
EUDAMED represents a fundamental shift toward lifecycle-based, data-driven regulation. Organizations that invest in structured data management, integrated RIM solutions, and strong governance frameworks are better positioned to reduce risk, improve efficiency, and support sustainable growth in the European market.
By embedding EUDAMED compliance into everyday regulatory operations, medical device companies can enhance regulatory confidence, improve operational resilience, and contribute to safer patient outcomes.
Q & A
1. What are the six EUDAMED modules and their purposes?
The six modules cover actor registration, UDI and device registration, notified bodies and certificates, clinical investigations and performance studies, vigilance and post-market surveillance, and market surveillance. Each supports a specific aspect of transparency, traceability, and oversight.
2. Which stakeholders are affected by each module?
Manufacturers, authorized representatives, importers, notified bodies, clinical study sponsors, and competent authorities are affected, depending on their role in the device lifecycle.
3. How does structured data in EUDAMED affect submissions and traceability?
Structured data improves consistency, enables automation, and supports end-to-end traceability across registration, certification, and post-market activities.
4. What challenges do medical device teams face with EUDAMED adoption?
Common challenges include data quality issues, fragmented systems, limited resources, and manual workflows that increase error risk.
