European Database on Medical Devices (EUDAMED): Objectives

European database on medical devices (EUDAMED) is the European Commission’s centralized IT system for medical device and IVD regulation. It has been designed to enhance transparency, traceability, and coordination across EU Member States. EUDAMED serves as the digital backbone for regulatory oversight across the EU medical device ecosystem.

What is EU MDR?

To understand EUDAMED, it is important to understand what is EU MDR. European Union Medical Device Regulation (EU MDR) 2017/745 is a framework governing safety and performance of medical devices in EU. EU MDR aims to address gaps in regulatory oversight and improve patient safety. MDR applies to a wide range of products, including traditional medical devices, implantables, aesthetic devices, and software with medical purposes. EU MDR introduces stricter requirements for clinical evaluation, post-market surveillance, traceability through (UDI), and transparency via the EUDAMED database. Manufacturers must comply with detailed safety and performance standards mentioned in the regulation.

What is European database on medical devices?

European database on medical devices (EUDAMED) is the European Commission’s centralized digital platform established under the EU Medical Device Regulation (MDR 2017/745). It is aimed to enhance transparency, traceability, and regulatory coordination across the European Union. It integrates six interconnected modules, namely actor registration, UDI/device registration, notified bodies and certificates, clinical investigations, vigilance and post-market surveillance, and market surveillance. Each module is designed to streamline regulatory processes, improve public access to device information, and strengthen post-market oversight. By centralizing data on medical devices, economic operators, clinical studies, and safety reports, EUDAMED supports harmonized market surveillance. Additionally, it fosters greater trust in the safety and performance of medical devices across the EU.

What is the concept of EUDAMED in EU MDR?

EUDAMED is a key regulatory aspect under EU MDR. EUDAMED is designed to fulfil the following core regulatory functions under the EU MDR:

• Ensure transparency of medical device information and regulatory activities
• Enable traceability of medical devices and economic operators via UDI and SRN
• Facilitate coordination among Competent Authorities, Notified Bodies, and the European Commission
• Strengthen post-market surveillance and vigilance reporting
• Streamline clinical investigation management and performance study tracking

6 Core objectives of European database on medical devices (EUDAMED)

We have provided a detailed breakdown of the core objectives of the European database on medical devices (EUDAMED). 

1. Transparency across the EU market: EUDAMED aims to make essential information about medical devices, manufacturers, and regulatory activities accessible to the public. By publishing data on device registration, certificates, and clinical investigations, it fosters trust among patients, healthcare professionals, and regulators. Furthermore, EUDAMED enables stakeholders to verify manufacturer credentials, conformity assessments, and device status.
2. Traceability of devices and economic operators: EUDAMED links each device to its Unique Device Identification (UDI), thereby allowing precise tracking throughout its lifecycle. Manufacturers, authorized representatives, importers, and sponsors are registered and assigned a Single Registration Number (SRN) to ensure accountability. It tracks device versions, certificates, and post-market changes, supporting forensic traceability in case of incidents or recalls.
3. Enhanced vigilance and post-market surveillance: The European database on medical devices centralizes serious incident and Field Safety Corrective Action (FSCA) reporting, thereby enabling faster response and trend analysis. It collects and shares Periodic Safety Update Reports (PSURs) for higher-risk devices. Additionally, it helps competent authorities identify emerging risks and coordinate corrective actions across member states.
4. Coordination among competent authorities and notified bodies: EUDAMED facilitates secure data exchange between national authorities, Notified Bodies, and the European Commission. It tracks conformity assessment certificates and Notified Body activities to prevent duplication or fraud. Moreover, it supports coordinated inspections, enforcement actions, and surveillance campaigns.
5. Streamlined clinical investigation and performance study management: Sponsors can submit applications for clinical investigations and performance studies directly through EUDAMED. Authorities and sponsors can monitor approvals, amendments, and results in real time. Furthermore, it promotes harmonized evaluation and public access to clinical evidence supporting device safety and performance.
6. Foundation for future regulatory harmonization: EUDAMED sets the stage for pan-European digital regulatory infrastructure, thereby aligning with global initiatives like IMDRF. It is designed to accommodate future modules, data types, and regulatory expansions. Furthermore, it encourages integration with national databases, manufacturer systems, and international platforms.

What are the six modules of European database on medical devices (EUDAMED)?

European database on medical devices is composed of six interlinked modules. Each module serves a distinct regulatory function to support EU MDR compliance. Together, they create a unified digital infrastructure for device regulatory oversight, transparency, and safety.

1. Actor registration module

The actor registration module registers all economic operators, i.e., manufacturers, authorized representatives, importers, and clinical investigation sponsors. It assigns a Single Registration Number (SRN) to each actor, which is required for accessing other modules. This module establishes accountability and traceability of all parties involved in device lifecycle.

2. UDI/device registration module

The UDI/device registration module captures Unique Device Identification (UDI) and device-specific data. Basic UDI-DI and UDI-DI entries, device risk class, intended purpose, and regulatory status are recorded. Thus, this module enables precise tracking of devices across the EU market and supports public transparency.

3. Notified bodies and certificates module

This module records notified body details and conformity assessment certificates. CE certificates issued under MDR/IVD and scope of designation for each notified body are covered in this module. Hence, this module prevents duplication and fraud and allows competent authorities to monitor certification activities.

4. Clinical investigations and performance studies module

This module focuses on applications, approvals, and results of clinical investigations (MDR) and performance studies (IVDR). It covers submission portal for sponsors as well as status tracking and result publication. It promotes harmonized evaluation and public access to clinical evidence.

5. Vigilance and post-market surveillance module

This module focusses on centralizing reporting of serious incidents, Field Safety Corrective Actions (FSCA), and Periodic Safety Update Reports (PSURs). It covers incident trend analysis and coordination of corrective actions across member states. Thus, this module focusses on strengthening post-market safety and rapid response mechanisms.

6. Market surveillance module

The market surveillance module enables competent authorities to share surveillance activities, findings, and enforcement actions. This module covers inspection reports and non-compliance alerts. This facilitates coordinated oversight and enforcement across the EU.

Implications for manufacturers

• Early registration: Proactively register in the Actor module to obtain a Single Registration Number (SRN).
• Data readiness: Prepare structured data for UDI/device registration and vigilance reporting.
• System integration: Align internal QMS and regulatory systems with EUDAMED’s architecture for seamless compliance.

Operational impact

For manufacturers and stakeholders, European database on medical devices introduces:

• Mandatory digital registration of actors and devices
• Real-time visibility into regulatory status and certificates
• Streamlined vigilance reporting and corrective action coordination
• Public access to device and clinical data for informed decision-making

EUDAMED readiness pro tips for MDR compliance

1. Build a digital dashboard to track EUDAMED module status, deadlines, and data quality
2. Conduct mock audits using EUDAMED data extracts and simulated authority queries
3. Verify alignment of SRN with internal regulatory systems and submission templates
4. Confirm CE certificates are uploaded by Notified Body
5. Train cross-functional teams on EUDAMED workflows and MDR linkages
6. Align clinical data with device performance claims and risk analysis
7. Identify MDR-regulated clinical investigations requiring EUDAMED submission
8. Harmonize EUDAMED inputs with global submissions
9. Prepare internal response protocols for inspections and enforcement actions
10. Align PMS plans with surveillance trends and feedback loops
11. Document corrective actions and regulatory correspondence

Therefore, European database on medical devices (EUDAMED) is needed to unify and modernize the EU’s medical device regulatory landscape. It enhances transparency, traceability, and coordination across Member States, thereby ensuring safer and more accountable device regulatory oversight. Drop an email at [email protected] or call/Whatsapp on 9996859227 for any guidance on EUDAMED or EU MDR compliance requirements.