The European Database on Medical Devices (EUDAMED) is an IT system developed by the European Commission to enhance the transparency, traceability, and coordination of information regarding medical devices available in the European Union (EU) market. Established under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), EUDAMED aims to provide a comprehensive overview of the lifecycle of all medical devices and in vitro diagnostic devices within the EU.
Structure and Modules of EUDAMED
EUDAMED is structured around six interconnected modules, each serving a specific function:
- Actor Registration: Enables economic operators—including manufacturers, authorized representatives, system/procedure pack producers, and importers—to register and obtain a Single Registration Number (SRN). This unique identifier ensures consistent identification across the EU.
- UDI/Device Registration: Facilitates the submission of Unique Device Identifier (UDI) information by manufacturers, allowing for easier traceability of medical devices. This aligns with global standards, such as the FDA’s Global Unique Device Identification Database (GUDID).
- Notified Bodies and Certificates: Allows Notified Bodies to register information regarding certificates issued, including amendments, suspensions, withdrawals, or refusals. This module enhances transparency and public access to certification details.
- Clinical Investigations and Performance Studies: Manages the submission and assessment of clinical investigation applications, performance studies, and related notifications, ensuring compliance with regulatory requirements.
- Vigilance and Post-Market Surveillance: Enables the reporting and monitoring of serious incidents, field safety corrective actions, and periodic safety update reports, strengthening post-market oversight.
- Market Surveillance: Assists Competent Authorities in recording and sharing activities related to market surveillance, promoting coordinated oversight across member states.
Implementation Timeline and Current Status
As of January 2025, the implementation of EUDAMED is progressing with a gradual rollout of its modules:
- Available Modules:
- Actor Registration: Available since December 2020.
- UDI/Device Registration: Available since October 2021.
- Notified Bodies and Certificates: Available since October 2021, excluding certain functionalities like the mechanism for scrutiny and the clinical evaluation consultation procedure (CECP).
- Under Development:
- Vigilance and Post-Market Surveillance
- Clinical Investigations and Performance Studies
- Market Surveillance
The European Commission has adopted a gradual rollout approach for EUDAMED. According to Regulation (EU) 2024/1860, the mandatory use of each module will commence six months after it is declared functional following an independent audit and the publication of a Commission notice in the Official Journal of the European Union.
Benefits of EUDAMED
Once fully operational, EUDAMED is expected to:
- Enhance Transparency: By providing public access to information about medical devices, manufacturers, and certificates, stakeholders, including healthcare professionals and patients, can make informed decisions.
- Improve Traceability: The UDI system facilitates the tracking of devices throughout their lifecycle, aiding in swift responses to safety concerns and recalls.
- Strengthen Market Surveillance: Competent Authorities will have access to comprehensive data, enabling more effective monitoring and enforcement of regulatory compliance.
- Align with Global Standards: EUDAMED’s functionalities align with international databases, such as the FDA’s GUDID, promoting global harmonization in medical device regulation.
Eudamed Requirements
From the regulation point of view, the functions of the EUDAMED are mentioned in Article 33 of EU MDR 2017/745, where it is reported:
Eudamed shall include the following electronic systems:
(a) the electronic system for registration of devices referred to in Article 29(4);(b) the UDI-database referred to in Article 28; (c) the electronic system on registration of economic operators referred to in Article 30; (d) the electronic system on notified bodies and on certificates referred to in Article 57; (e) the electronic system on clinical investigations referred to in Article 73; (f) the electronic system on vigilance and post-market surveillance referred to in Article 92; (g) the electronic system on market surveillance referred to in Article 100.
This is an example of the UDI-related information to be submitted in EUDAMED for Medical Devices:
Conclusions
EUDAMED represents a significant advancement in the EU’s regulatory framework for medical devices and in vitro diagnostic devices. By centralizing critical information and enhancing transparency, it aims to improve the safety and performance monitoring of devices distributed within Europe. Stakeholders are encouraged to engage with the available modules and prepare for the forthcoming mandatory requirements as the system progresses toward full functionality.
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