Eudamed Roll-Out: Everything You Need to Know for Medical Device Compliance
The phased roll-out of Eudamed, the European database for medical devices, is one of the most significant changes in the regulatory landscape for manufacturers. Under Regulation (EU) 2024/1860, the European Union has outlined a clear plan for the gradual implementation of Eudamed, with specific deadlines for each module to become mandatory for manufacturers, importers, and authorized representatives.
Understanding the requirements of Eudamed, its modules, and how they will affect medical device registration is crucial to ensure compliance with the new MDR and IVDR regulations. In this article, we will break down the key aspects of the Eudamed roll-out, explain its modules, and provide insights on how to prepare for these changes to avoid delays and ensure compliance.
What is Eudamed and Why is It Important?
Eudamed is the European database for medical devices, designed to improve transparency and traceability of devices on the EU market. By centralizing information related to medical device registration, post-market surveillance, and clinical investigations, Eudamed aims to improve patient safety and strengthen the EU medical device regulations.
The introduction of Eudamed under the new Regulation (EU) 2024/1860 establishes a phased approach to its implementation, where the database will be gradually rolled out across several modules. Each of these modules will become mandatory only after a full review and confirmation of their functionality, which is expected to occur 6 months after the 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 pivotal role in the regulatory framework for medical device compliance. Manufacturers must familiarize themselves with these modules to avoid disruption in their operations and ensure they comply with the new medical device regulations.
1. Actor Registration (Actor Module)
The Actor module requires all economic operators, including manufacturers, importers, and authorized representatives, to register in Eudamed. Actor registration is a prerequisite to accessing other modules of the system, such as UDI/device registration and vigilance reporting.
Manufacturers, in particular, will need to 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 the Actor module becomes mandatory.
2. UDI/Device Registration (UDI/DEV Module)
The UDI/Device module is designed to ensure that each medical device is properly identified and tracked throughout its lifecycle. As part of medical device traceability, the UDI (Unique Device Identifier) plays a critical role in enhancing device safety and simplifying post-market surveillance efforts.
The UDI/DEV module will become mandatory once confirmed functional. Manufacturers must ensure their devices are registered with a valid UDI, as failure to comply with traceability requirements could result in significant compliance and market access issues.
3. Notified Bodies and Certificates (NB/CRF Module)
The Notified Bodies and Certificates module will allow for the registration of certificates and decisions made by notified bodies. This module is essential for continued monitoring of medical device compliance across the EU.
Manufacturers will need to ensure that their certifications are registered in this module, particularly when updates or modifications are made to certificates.
4. Post-Market Surveillance (PMS) and Vigilance (VGL Module)
As per MDR and IVDR regulations, post-market surveillance is a mandatory requirement for all medical devices placed on the EU market. The Vigilance module will facilitate the submission of adverse event reports, including serious incidents, trends, and corrective actions.
Manufacturers must ensure their post-market surveillance system is integrated with Eudamed, enabling efficient reporting of safety concerns and incidents as required under EU regulations.
5. Clinical Investigations and Performance Studies (CI/PS Module)
The CI/PS module enables the submission of clinical investigation and performance study data, supporting the ongoing assessment of device safety and effectiveness. Registration for clinical investigations must be completed before they can be initiated within the EU.
Timeline for the Eudamed Roll-Out
The timeline for the Eudamed roll-out will see each module become mandatory 6 months after the Official Journal of the European Union publishes its confirmation of functionality. This gives manufacturers time to complete Actor registration and UDI/device registrations before they become mandatory.
Given the gradual nature of the implementation, it is crucial that manufacturers begin their preparations now to ensure compliance with Eudamed’s mandatory modules and avoid last-minute delays.
Why Early Registration Is Critical
One of the key factors in ensuring compliance with Eudamed is early registration. Voluntary registration is already available for several modules, including the Actor module and UDI/Device module. Manufacturers should take advantage of this opportunity to avoid potential backlogs when registration becomes mandatory.
By registering early, manufacturers will have time to address any issues with their data and ensure they meet all necessary regulatory requirements for medical device traceability and compliance.
Stay Ahead of Eudamed’s Implementation
The phased roll-out of Eudamed under Regulation (EU) 2024/1860 is a significant development for the medical device industry in the EU. Understanding the key modules, the mandatory registration process, and the implementation timeline is essential to maintaining compliance and securing market access.
Manufacturers must act now to ensure they are fully prepared for the upcoming changes. Early registration, particularly for the Actor module and UDI/Device module, is critical to avoid compliance issues when the modules become mandatory.
Read and download the full article here to learn how to best prepare for the Eudamed roll-out and ensure your medical device compliance.
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