Understanding EUDAMED and the Latest Regulatory Updates

What is EUDAMED?

EUDAMED, or the European Database on Medical Devices, is an extensive IT system developed by the European Commission to centralize and streamline information regarding medical devices, in vitro diagnostic devices (IVDs), and associated economic operators. Its primary goals are to enhance transparency, provide better access to information for the public and healthcare professionals, and improve coordination between EU Member States. EUDAMED comprises six distinct modules:

1. Actor Registration
2. Unique Device Identification (UDI) and Device Registration
3. Notified Bodies and Certificates
4. Clinical Investigations and Performance Studies
5. Vigilance and Post-Market Surveillance
6. Market Surveillance

Purpose of EUDAMED

EUDAMED aims to ensure a high level of safety for patients by improving the monitoring of medical devices throughout their lifecycle. The database facilitates the following:

• Transparency: Ensures that all stakeholders, including patients and healthcare professionals, have access to essential information about medical devices.
• Regulation Compliance: Helps manufacturers and economic operators comply with EU regulations.
• Market Surveillance: Enhances coordination among EU Member States for market surveillance activities.
• Reporting and Vigilance: Provides a streamlined process for reporting incidents and managing corrective actions.

Is EUDAMED Mandatory?

Currently, the use of EUDAMED is not mandatory. Several modules are available for voluntary use, including the Actor Registration module (since December 2020) and the UDI/Device Registration and Notified Bodies and Certificates modules (since October 2021). The full mandatory implementation of EUDAMED is contingent upon the completion and functionality of all its modules.

New Advancements and Regulations

On July 9, 2024, a new regulation, (EU) 2024/1860, was published, amending the Medical Device Regulation (MDR) (EU 2017/745) and the In Vitro Diagnostic Regulation (IVDR) (EU 2017/746). This amendment introduces several key changes:

1. Phased Introduction of EUDAMED:
   • The EUDAMED database will become operational module by module.
   • Legacy or compliant devices must be registered within 12 months of the module’s functionality notice.
   • Notified bodies must register certificates within 18 months.
2. Obligation to Report Supply Chain Disruptions:
   • Manufacturers and economic operators must report supply chain disruptions or discontinuations six months in advance.
   • In critical situations where no market alternatives exist, immediate reporting to competent authorities and affected stakeholders is required.
3. Extension of the Transition Period for Specific IVDs:
   • The transition period for IVDs requiring conformity assessment by a notified body is extended by two years if specific criteria are met.
   • Manufacturers must establish a Quality Management System (QMS) by May 26, 2025, and maintain it continuously.
   • Formal applications for certification must be submitted based on the device’s risk class, and contracts with notified bodies must be in place.

Expected Timelines for Mandatory EUDAMED Use

According to the updated regulations, the mandatory use of each EUDAMED module will commence six months after it is declared functional following an independent audit and publication of a notice in the Official Journal of the European Union (OJEU). The anticipated timelines are as follows:

• Actor Registration: Mandatory within six months of the notice.
• UDI/Device Registration: Manufacturers must register their devices before placing them on the market within 12 months of the notice.
• Vigilance and Post-Market Surveillance: Manufacturers must report serious incidents and submit trend reports within 12 months of the notice.
• Clinical Investigations and Performance Studies: Timelines for this module are yet to be finalized but are expected by Q3 2026.

Conclusion

Regulation (EU) 2024/1860 represents a significant step toward the full implementation of EUDAMED, aiming to enhance patient safety, ensure continuous market supply of critical devices, and improve regulatory compliance across the EU. While the full mandatory use of EUDAMED is still in progress, the phased roll-out and new obligations provide a structured pathway for manufacturers and economic operators to adapt to the evolving regulatory landscape.

Stay informed about the latest developments and ensure compliance by regularly checking updates from the European Commission and other relevant regulatory bodies.

For more details and guidance, refer to the European Commission’s website and the latest regulatory documents.