What is EUDAMED and why is it important for medical device manufacturers?

Nicolas Blanquet

June 3, 2024

Digital transformation impacts every sector, including medical devices. At the heart of this regulatory revolution lies EUDAMED (European Database on Medical Devices), an ambitious initiative by the European Commission that redefines transparency and traceability standards for medical devices in Europe.

For manufacturers, understanding EUDAMED is not just a matter of compliance but also a strategic opportunity in an increasingly demanding European market.

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What Exactly Is EUDAMED?

EUDAMED is much more than a simple database. It’s a comprehensive digital ecosystem designed to centralize information on medical devices marketed in Europe.

Born from the European MDR (2017/745) and IVDR (2017/746) regulations, this platform aims to replace the old directives by providing a more rigorous regulatory framework to meet contemporary challenges in the medical sector.

EUDAMED’s objectives are multiple:

Strengthen transparency in the medical device market
Improve coordination among national authorities of the 27 Member States
Ensure better product traceability
Enhance post-market vigilance and surveillance
Facilitate information exchange among stakeholders

A Modular Architecture Addressing Specific Needs

EUDAMED is structured around six interconnected modules:

1. Actor Registration Module

This first module allows economic operators (manufacturers, authorised representatives, importers, and SPP producters) to register and obtain a Single Registration Number (SRN), essential for subsequent steps.

2. Certificates and Notified Bodies Module

This module records information on issued certificates, including modifications, suspensions, reinstatements, withdrawals, or refusals.

3. Device Registration and UDI Database Module

The system’s core, this module centralizes information on each medical device via its unique identifier (UDI-DI) and grouping by family (Basic UDI-DI), facilitating identification and traceability.

4. Vigilance and Post-Market Surveillance Module

Crucial for patient safety, this module supports incident reporting and follow-up, as well as coordination of corrective actions.

5. Market Surveillance Module

This module enables effective coordination among competent authorities to ensure robust market surveillance.

6. Clinical Investigations Module

Dedicated to clinical study data, this module increases transparency regarding the scientific evidence supporting device safety and performance.

Why Is EUDAMED Transforming the Medical Device Sector?

An Accelerating Timeline

With Regulation (EU) 2024/1860, the European Union clarified the implementation timeline: the Commission’s notice on the functionality of the UDI/DEV module is published in the Official Journal of the EU by the end of September 2025.

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This gradual yet firm timeline illustrates Europe’s determination to make EUDAMED the cornerstone of medical device regulation.

A Multifaceted Transformation

For manufacturers, the impact of EUDAMED goes well beyond mere regulatory compliance:

Enhanced Transparency and Trust

Publicly accessible EUDAMED information will enable healthcare professionals and patients to make more informed choices, rewarding manufacturers who demonstrate commitment to quality and safety.

End-to-End Traceability

The unique identification system simplifies tracking devices throughout their lifecycle—from manufacture to end use—enabling targeted and efficient recalls if necessary.

Streamlined Access to the European Market

By standardizing registration requirements across all 27 Member States, EUDAMED reduces administrative complexity for manufacturers operating at a European scale.

Improved Vigilance and Responsiveness

Centralized incident reporting allows faster detection of potential issues and more effective coordination of corrective measures.

Challenges and Opportunities for Manufacturers

Challenges to Overcome

Adapting to EUDAMED presents several significant challenges:

Technical Complexity: Data requirements are numerous and detailed, requiring deep understanding of the EUDAMED data model.
Initial Investment: Compliance may demand significant resources in terms of time, personnel, and technology.
Data Integrity: Following ALCOA+ principles, data integrity becomes a major issue requiring robust processes.
Staff Training: Teams must be trained to understand and correctly apply the new requirements.

Opportunities to Seize

These challenges come with significant strategic opportunities:

Competitive Differentiation: Companies that master EUDAMED quickly can stand out in a competitive market.
Improved Internal Processes: Preparing for EUDAMED can be an opportunity to streamline and optimize data management processes.
Stimulated Innovation: Better understanding of device performance and user feedback can drive innovation.
Facilitated Expansion: Solid compliance opens doors more easily to the entire European market.

Preparing Strategically for EUDAMED

To tackle this paradigm shift confidently, here are five strategic actions to take now:

1. Assess Your Current Situation

Begin by quantifying affected devices and evaluating the quality of your current data. This step is crucial to determine whether a manual or automated approach is more suited.

2. Define Clear Governance

Establish who is responsible for each part of the EUDAMED data registration and maintenance process. Clear governance is the foundation of successful implementation.

3. Train Your Teams

Invest in training your staff on EUDAMED specifics and best practices for data integrity.

4. Adapt Your IT Systems

Evaluate whether your current systems can support EUDAMED requirements or if new technology investments are necessary.

5. Start Early and Progress Methodically

Do not underestimate the time needed for preparation. Starting early allows a methodical and controlled transformation.

Conclusion

EUDAMED represents much more than a new regulatory obligation: it signifies a profound transformation of the medical device landscape in Europe. For manufacturers, it is both a challenge to meet and an opportunity to seize.

Those who adapt quickly and effectively to this new reality will not only maintain access to the European market—they will strengthen their competitive position and reputation in a sector where trust is paramount.

The clock is ticking, and with deadlines in 2026 approaching, the time to act is now.

FAQs

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What exactly is EUDAMED and why was it created?
EUDAMED (European Database on Medical Devices) is a centralized European database created by the European Commission to revolutionize transparency and traceability of medical devices in Europe. This digital platform replaces old directives with a more rigorous regulatory framework, stemming from the MDR (2017/745) and IVDR (2017/746) regulations. Its primary objective is to strengthen patient safety, improve coordination among the 27 Member States, and facilitate information exchange between all stakeholders in the medical sector.
What are the six EUDAMED modules and their main functions?
EUDAMED is structured around six interconnected modules. The Actor Registration Module allows economic operators to obtain a unique registration number (SRN). The Certificates and Notified Bodies Module centralizes information on issued certificates. The Device Registration and UDI Database Module serves as the system’s core with unique identification of each device. The Vigilance and Post-Market Surveillance Module manages incidents and corrective actions. The Market Surveillance Module coordinates between competent authorities. Finally, the Clinical Investigations Module provides transparency on scientific evidence.
What are the key deadlines for EUDAMED compliance?
With Regulation (EU) 2024/1860, the timeline has been clarified: the Commission’s notice on the functionality of the UDI/DEV module must be published in the EU Official Journal by the end of September 2025. Devices placed on the market for the first time after January 1, 2026, must be registered immediately, while those marketed before this date must be registered before July 1, 2026. This progressive yet firm timeline illustrates Europe’s determination to make EUDAMED the cornerstone of medical device regulation.
Who is required to register in EUDAMED?
All economic operators involved in the medical device supply chain are concerned: manufacturers, system and procedure pack producers (SPP), authorized representatives, and importers must register in the Actor Module. Only manufacturers and SPPs can register medical devices in the UDI/DEV module. Distributors, while having traceability and surveillance obligations, cannot register directly in EUDAMED but must rely on publicly available information.
What is the difference between UDI-DI and Basic UDI-DI?
The UDI-DI (UDI Device Identifier) uniquely identifies each medical device and must appear on product labeling as a barcode and in plain text. The Basic UDI-DI groups a family of devices with the same intended purpose and essential characteristics. It must never appear on labeling but serves as a primary key in EUDAMED and in regulatory documentation (certificates, declarations of conformity). This distinction is fundamental to understanding the EUDAMED data architecture.
How do you manage Legacy Devices in EUDAMED?
Legacy Devices are devices marketed under old directives (MDD, IVDD) that benefit from transition periods. They must be registered in EUDAMED before July 1, 2026, unless the same device is already registered under MDR or is no longer marketed. For their Basic UDI-DI, two options exist: use the existing UDI-DI with the “B-” prefix or generate an EUDAMED-DI. Important: there is a one-to-one relationship between the UDI-DI and Basic UDI-DI of the Legacy Device.
Should exchanges with EUDAMED be automated?
The choice between manual entry and automation depends primarily on the volume of medical devices. For low volumes, manual entry or XML file upload may suffice. However, all other cases require automatic “machine to machine” (M2M) synchronization to efficiently manage creation, modifications, and error traceability. Automation becomes essential with the multiplication of international regulatory databases and digitalization objectives.
What are the main challenges for manufacturers?
Challenges include the technical complexity of data requirements, initial investment in human and technological resources, compliance with data integrity according to ALCOA+ principles, and team training. However, these challenges come with strategic opportunities: competitive differentiation, improvement of internal processes, innovation stimulation, and facilitated European expansion.
How does EUDAMED differ from GUDID?
Although both concern medical device tracking, EUDAMED and GUDID have fundamental differences. EUDAMED covers all medical devices marketed in the EU with a complex modular architecture integrating surveillance, certificates, and clinical investigations. GUDID focuses primarily on unique identification in the United States with a simpler model. The concepts of medical devices and classes are not identical between the two systems, making their data models difficult to reconcile.
How can you effectively prepare for EUDAMED?
Five strategic actions are recommended: assess your current situation by quantifying affected devices, define clear governance of responsibilities, train your teams on EUDAMED specifics, adapt your IT systems to new requirements, and start early with a methodical approach. Anticipation is key: with 2026 deadlines approaching, the time to act is now.

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