Eudamed Modules: Key Steps for Medical Device Compliance
What is Eudamed and Why is It Important?
Eudamed is the European database for medical devices, designed to improve transparency, traceability, and regulatory oversight across the EU market. By centralizing data related to medical device registration, post-market surveillance, and clinical investigations, Eudamed enhances patient safety and strengthens regulatory compliance.
The introduction of Eudamed modules under Regulation (EU) 2024/1860 follows a phased approach, ensuring each module becomes mandatory only after its full review and confirmation of functionality, which is expected six months after official publication in the Official Journal of the European Union (OJEU).
The Key Eudamed Modules and Their Impact on Manufacturers
The Eudamed roll-out consists of six essential modules, each playing a critical role in regulatory compliance for medical devices. Manufacturers, importers, and authorized representatives must understand and integrate these modules into their operations to comply with MDR and IVDR regulations.
1. Actor Registration (Actor Module)
The Actor module requires all economic operators—including manufacturers, importers, and authorized representatives—to register in Eudamed. This is a prerequisite for accessing other Eudamed modules, such as UDI/device registration and vigilance reporting.
Manufacturers must obtain a Single Registration Number (SRN) through the Actor module before placing devices on the EU market. Early registration is highly recommended to avoid delays when this module becomes mandatory.
2. UDI/Device Registration (UDI/DEV Module)
The UDI/Device module ensures that each medical device is properly identified and tracked throughout its lifecycle. The Unique Device Identifier (UDI) is essential for medical device traceability, enhancing safety and simplifying post-market surveillance.
Manufacturers must ensure their devices are registered with a valid UDI before the UDI/DEV module becomes mandatory, as non-compliance could lead to regulatory penalties and market access issues.
3. Notified Bodies and Certificates (NB/CRF Module)
The Notified Bodies and Certificates module allows for the registration and monitoring of certificates issued by notified bodies. This module is crucial for ensuring ongoing compliance with EU medical device regulations.
Manufacturers should ensure that their certifications are properly registered in this module, particularly when updates or modifications are made.
4. Post-Market Surveillance and Vigilance (PMS/VGL Module)
Post-market surveillance (PMS) and vigilance reporting are mandatory requirements under MDR and IVDR. The PMS/VGL module facilitates the submission of adverse event reports, serious incidents, trend analyses, and corrective actions.
To comply with EU regulations, manufacturers must integrate their post-market surveillance systems with Eudamed to enable efficient safety reporting.
5. Clinical Investigations and Performance Studies (CI/PS Module)
The CI/PS module supports the submission and monitoring of clinical investigations and performance studies. Manufacturers conducting clinical trials within the EU must register their studies before they can proceed.
Eudamed Roll-Out Timeline
Each Eudamed module will become mandatory six months after its confirmation of functionality is published in the Official Journal of the European Union (OJEU). This timeline gives manufacturers a crucial window to complete their Actor registration and UDI/device registrations before they become mandatory.
Why Early Registration is Critical
Early registration is one of the key strategies to ensure smooth compliance with Eudamed modules. Voluntary registration is already open for some modules, including the Actor module and UDI/Device module.
Stay Ahead of Eudamed’s Implementation
The phased roll-out of Eudamed modules under Regulation (EU) 2024/1860 marks a pivotal development in the medical device industry within the EU. Understanding the mandatory registration process, key modules, and implementation timeline is crucial for manufacturers to maintain compliance and secure market access.
For expert guidance on Eudamed modules and regulatory compliance, contact us today. We are here to support you in achieving full compliance with EU medical device regulations.
