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EUDAMED 3.8.0: New Version Deployed with Enhanced Features

Release Date: May 15, 2024


The European Database on Medical Devices (EUDAMED) has launched its latest version, 3.8.0, as part of the ongoing effort to improve the transparency and traceability of medical devices within the EU. This update is crucial for manufacturers, regulatory bodies, and stakeholders in the medical device industry.


Key Updates in EUDAMED 3.8.0


The new release introduces several enhancements and new features aimed at streamlining the submission and management of medical device information. Here are the highlights:


  1. Improved UDI-DI/Device Module: The UDI-DI/Device module, which allows manufacturers to submit their Unique Device Identifiers (UDIs) and related device information, has been updated for better usability and functionality. This module ensures that device information is accessible to all stakeholders, enhancing transparency and traceability.

  2. Enhanced User Interface: Version 3.8.0 brings a more intuitive and user-friendly interface, making it easier for users to navigate the system and enter data accurately. The improved interface helps reduce the learning curve and increases efficiency in managing device information.

  3. Regulation Compliance: The update ensures continued compliance with Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices. These regulations require an EU identification system for medical devices based on a UDI, and EUDAMED 3.8.0 supports this mandate effectively.

  4. Data Validation and Quality Checks: New data validation rules and quality checks have been introduced to ensure that the information entered into the database is accurate and complete. This helps maintain high data integrity and reliability.

  5. Expanded Reporting Capabilities: The release enhances reporting capabilities, allowing users to generate more detailed and customizable reports. This functionality supports better decision-making and regulatory oversight.

  6. Security and Performance Enhancements: To protect sensitive data and ensure system reliability, EUDAMED 3.8.0 includes the latest security updates and performance optimizations. These enhancements help safeguard the database against potential threats and improve overall system performance.


Accessing the Release Notes


For a comprehensive overview of all the changes and new features in EUDAMED 3.8.0, the Information Centre – EUDAMED provides a detailed release note document. This document is essential for understanding the full scope of the update and can be accessed [here](https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/release_note_v3_8.pdf).


Importance of UDI


The Unique Device Identifier (UDI) system is a cornerstone of the EU’s efforts to enhance the safety and traceability of medical devices. By requiring manufacturers to submit their UDIs and related information to EUDAMED, the system aims to:


  • Improve the ability to trace devices throughout their lifecycle.

  • Enhance post-market surveillance and vigilance activities.

  • Support better incident reporting and corrective actions.

  • Facilitate the identification of counterfeit devices.


Conclusion


The deployment of EUDAMED version 3.8.0 marks a significant step forward in the EU’s regulatory framework for medical devices. With its enhanced features and improved user experience, this update is set to provide substantial benefits to manufacturers, regulators, and other stakeholders in the medical device industry.


Manufacturers are encouraged to familiarize themselves with the new features and updates in EUDAMED 3.8.0 to ensure compliance with EU regulations and to take full advantage of the system's capabilities. For any questions or further information, stakeholders can refer to the release note document or contact the Information Centre – EUDAMED.


Stay tuned for more updates as EUDAMED continues to evolve and support the safety and effectiveness of medical devices across the European Union.


EUDAMED user guide UDI Devices
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