The 6 EUDAMED Modules — Clearly Explained

Introduction

EUDAMED (European Database on Medical Devices) marks a major step forward in the regulation of medical devices across Europe. Established under the MDR (Regulation EU 2017/745) and IVDR (Regulation EU 2017/746), this comprehensive database is structured into six dedicated modules, each serving a specific regulatory function. Understanding these modules is essential for medical device manufacturers working toward compliance with the new European regulatory landscape.

A Modular Architecture Designed for Transparency and Safety

EUDAMED was created to enhance transparency, strengthen coordination between EU Member State authorities, and improve traceability of medical devices on the European market. To achieve these goals, the database is divided into six distinct but interconnected modules.

Module 1: Actor Registration

Purpose:

Enables the registration of economic operators as defined by European regulations.

Key Features:

• • Assignment of a Single Registration Number (SRN) to each economic operator

• • Management of identification and contact details

• • Verification and validation by Competent Authorities

Who it concerns:

• • Manufacturers

• • System & Procedure Pack producers

• • Authorized Representatives

• • Importers

Important Notes:

• • Economic operators must register in this module before submitting any device data

• • Information updates must be made within one week of any change

• • Confirmation of data accuracy is required annually, then every two years

Module 2: UDI/Device Registration

Purpose:

This module centralizes data on all medical devices placed on the EU market, using a Unique Device Identification (UDI) system to ensure traceability.

Key Features:

• • Device registration via UDI-DI (Device Identifier)

• • Grouping of related devices using Basic UDI-DI

• • Management of product characteristics and classification

Who it concerns:

• • Manufacturers

• • System & Procedure Pack producers

Important Notes:

• • Authorized Representatives and Importers have read-only access

• • Devices must be registered before being placed on the market

• • Mandatory fields include product features, target markets, and labeling details

Module 3: Notified Bodies and Certificates

Purpose:

This module contains information on CE certificates issued for medical devices and the Notified Bodies authorized to issue them.

Key Features:

• • Registration of CE certificates

• • Validation and monitoring of certificate status

• • Tracking of modifications and withdrawals

Who it concerns:

• • Notified Bodies

Important Notes:

• • Notified Bodies are listed in this module, not under “Actors”

• • Enables rapid verification of a device’s regulatory compliance

• • Certificates are linked to the Basic UDI-DI for traceability

Module 4: Clinical Investigations and Performance Studies

Purpose:

Manages data related to clinical investigations of medical devices and performance studies for in vitro diagnostic devices.

Key Features:

• • Registration of clinical investigations and performance studies

• • Monitoring of study outcomes

• • Information sharing between Competent Authorities

Who it concerns:

• • Manufacturers

• • Sponsors of clinical investigations

Important Notes:

• • EU Competent Authorities and the European Commission have access to these records

• • This module enhances transparency regarding clinical evidence supporting safety and effectiveness

Module 5: Vigilance and Post-Market Surveillance

Purpose:

Used to report and track adverse events involving medical devices after they have been placed on the market.

Key Features:

• • Reporting of serious incidents

• • Registration of Field Safety Corrective Actions (FSCAs)

• • Sharing of Field Safety Notices (FSNs)

• • Trend reporting

Who it concerns:

• • Manufacturers

• • Authorized Representatives (acting on behalf of manufacturers)

Important Notes:

• • Importers must inform manufacturers and authorities of incidents but do not directly report in this module

• • EU Competent Authorities and the European Commission can access this data

• • Critical for early detection of safety issues

Module 6: Market Surveillance

Purpose:

Facilitates coordination between Competent Authorities in monitoring medical devices on the EU market.

Key Features:

• • Information sharing on inspections and audits

• • Coordination of enforcement measures

• • Exchange of data on non-compliant products

Who it concerns:

• • Competent Authorities in EU Member States

Important Notes:

• • This module is primarily for regulatory authorities

• • Promotes consistent and efficient market surveillance across the EU

• • Shared insights may lead to coordinated regulatory action

Interconnecting the Modules: Basic UDI-DI as the Key Element

At the core of EUDAMED’s architecture lies the Basic UDI-DI, which links information across all six modules. This unique identifier groups devices with shared essential characteristics and provides a consistent reference point:

• • Used to register device groups in Module 2

• • Referenced in CE certificates in Module 3

• • Linked to clinical investigations in Module 4

• • Associated with incidents and corrective actions in Module 5

This interconnected structure ensures complete and consistent traceability throughout the product lifecycle.

Current Deployment Status

According to the Ackomas EUDAMED Practical Guide v3.2 (March 6, 2025):

Live Modules:

• • Actor Registration (live since December 2020)

• • Device/UDI Registration (live since September 2021)

• • Notified Bodies and Certificates

In Development:

• • Vigilance Module (expected 2025)

• • Clinical Investigations and Performance Studies (under consideration)

Challenges and Opportunities for Manufacturers

Key Challenges:

• • Complex data model: Each module requires unique but interrelated data elements

• • Data volume: Especially demanding for companies with extensive product catalogs

• • Data maintenance: Strict deadlines apply for updates

• • Data integrity: Must comply with ALCOA+ principles across all modules

Strategic Opportunities:

• • Centralized access: A single EU-wide point of registration

• • Improved traceability: End-to-end lifecycle visibility

• • Proactive safety monitoring: Better risk detection post-market

• • Enhanced access: Healthcare professionals and patients benefit from more complete information

Strategies for Effective Implementation

To navigate this regulatory transition successfully, manufacturers should consider the following best practices:

1. Modular Approach Tackle compliance one module at a time — begin with Actor Registration and follow as other modules are rolled out.

2. Assess Device VolumeEvaluate how many devices you need to register to determine the best approach:

• • Manual entry: suitable for low volumes

• • XML file uploads: semi-automated, more technical

• • Machine-to-machine (API) integration: recommended for scalability

3. Structured Data ManagementEstablish a consistent data structure that reflects relationships between Basic UDI-DI and UDI-DI while aligning with EUDAMED’s data model.

4. Training and GovernanceDefine clear data ownership and provide tailored training for internal teams involved in module-specific tasks.

Conclusion

Together, EUDAMED’s six modules form a robust ecosystem for medical device data management within the EU. While the rollout presents challenges, the system offers unmatched transparency and traceability across the device lifecycle.

For manufacturers, understanding the functionality and interplay of each module is essential for effective compliance. With a structured, strategic approach, economic operators can not only meet EUDAMED’s requirements but also benefit from the advantages of a centralized and integrated regulatory platform.

As the 2026 deadline for mandatory device registration approaches, preparing for EUDAMED should now be a strategic priority for all stakeholders in the medical device sector.

Need help navigating EUDAMED’s modules? Discover how the ACKOMAS solution can simplify your compliance process.

Learn More : https://www.ackomas.com/medical-device-compliance-solution/