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
Key Milestones in the Implementation of EUDAMED
2017 – The Official Adoption of MDR and IVDR
EUDAMED was identified as a crucial component of MDR and IVDR to ensure centralization and accessibility of medical device information. On April 5, 2017, the European Parliament formally adopted both regulations, which entered into force on May 25, 2017, setting a transition period of three years for MDR and five years for IVDR.
2019 – Initial Planned Go-Live Date for EUDAMED
Originally, EUDAMED was scheduled to launch on March 25, 2020, with a full transition by May 2020, but technical and regulatory challenges led the European Commission (EC) to delay its deployment.
2020 – Postponement Due to Technical Readiness and COVID-19
In December 2019, the EC announced that EUDAMED’s implementation would be postponed due to technical readiness issues, with a new go-live date set for May 2022. The COVID-19 pandemic further disrupted the timeline, leading to an extension of the MDR transition period until May 2021.
2021 – MDR Takes Effect Without EUDAMED
On May 26, 2021, the MDR became fully applicable, but EUDAMED was still not ready, prompting the EC to adopt a modular approach, allowing different sections to be deployed separately as they became available, shifting the full database launch to 2024.
2022 – Partial Deployment of EUDAMED Modules
By October 2021, three modules of EUDAMED were launched for voluntary use: Actor Registration Module, allowing manufacturers, authorized representatives, and importers to register; UDI/Device Registration Module, enabling the registration of Unique Device Identifiers (UDI) and medical devices; and Notified Bodies and Certificates Module, facilitating certification tracking.
2023 – Ongoing Development of Remaining Modules
Work continued on the remaining three modules: Clinical Investigations & Performance Studies, Market Surveillance & Vigilance, and Post-Market Surveillance, with the full launch of EUDAMED projected for Q2 2024.
2024 – Full Functionality Expected (Current Timeline)
By Q2 2024, the European Commission aims to complete the final modules of EUDAMED, with the expectation that by 2026, once all modules are functional and audited, EUDAMED will become fully mandatory for all economic operators.
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.
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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