The 6 EUDAMED Modules — Clearly Explained
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.
Updated October 2026
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.
Who it concerns:
- Manufacturers
- System & Procedure Pack producers
- Authorized Representatives
- Importers
Note: actor registration is a prerequisite to any device data submission. It is handled by each economic operator and is outside the scope of this guide, which focuses on device data.
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 EU certificates issued for medical devices and the Notified Bodies authorized to issue them.
Key Features:
- Registration of EU 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 EU 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
Under Regulation (EU) 2024/1860, each module becomes mandatory six months after its notice is published in the Official Journal of the European Union.
- Since 28 May 2026, EUDAMED is mandatory for new MDR and IVDR devices.
- Legacy devices must be registered by 27 November 2026.
- Notified Bodies complete the upload of pre-2026 certificates by May 2027.
The Vigilance and Clinical Investigations modules follow the same rule once their notice is published. See our EUDAMED compliance timeline.
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:
- Modular approach: organise device data by module, starting with the UDI/Device module and the certificate links, then prepare the data needed for vigilance.
- Assess Device VolumeEvaluate how many devices you need to register to determine the best approach:
Manual entry: suitable for low volumes
File-based uploads: semi-automated, more technical
Machine-to-machine (API) integration: recommended for scalability - Structured Data ManagementEstablish a consistent data structure that reflects relationships between Basic UDI-DI and UDI-DI while aligning with EUDAMED’s data model.
- 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.
With EUDAMED now mandatory, the challenge shifts from first registration to keeping device data consistent across modules over the product life cycle. Read how to maintain EUDAMED data over time.
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Download our comprehensive EUDAMED Guide for a deep dive into each module. Download the Guide : https://www.ackomas.com/guide-download/
