A New Standard for Transparency and Traceability in Medical Devices
Regulation (EU) 2024/1860 has introduced significant changes to MDR (EU) 2017/745 and IVDR (EU) 2017/746, facilitating the gradual implementation of Eudamed, the European database on medical devices. This system marks a crucial step towards greater transparency, traceability, and safety in the healthcare sector.
Since July 2023, Gruppo FarmaImpresa has been officially registered on Eudamed as a manufacturer and producer of systems and procedural kits. This registration represents an important milestone for the company, showcasing its commitment to upholding the highest standards of safety and quality in the medical device sector.
Through this registration, Gruppo FarmaImpresa assures its clients that its products are safe, effective, and fully compliant with regulations, contributing to public health protection and patient safety improvement.
This article will analyze in detail the practical implications of the introduced changes, focusing on implementation timelines, obligations for economic operators, and the functionality of Eudamed’s modules.
What is Eudamed?
Eudamed is an electronic platform designed to enhance the transparency and traceability of medical devices placed on the EU market. It consists of six main modules, each playing a specific role in managing information on medical devices, from economic operators to post-market surveillance.
The modules include:
- Actor Registration (ACT) Module
- UDI/Device Registration (UDI/DEV) Module
- Notified Bodies and Certificates (NB/CRF) Module
- Market Surveillance (MSU) Module
- Post-Market Surveillance and Vigilance (VGL) Module
- Clinical Investigations/Performance Studies (CI/PS) Module
Gradual Implementation of Eudamed: Details and Timelines
- Actor Registration (ACT) Module: Requires economic operators, such as manufacturers, authorized representatives, and importers, to register and obtain a Single Registration Number (SRN). This module is essential for enabling other activities in Eudamed, such as device registration and vigilance reporting.
- UDI/Device Registration (UDI/DEV) Module: Designed to manage the registration of medical devices using unique device identifiers (UDI-DI). Custom-made devices or those no longer placed on the market at the time of the module’s entry into force are exempt from registration unless subject to post-market surveillance actions.
- Notified Bodies and Certificates (NB/CRF) Module: Notified bodies must register certificates and related updates. This module will become mandatory six months after the notification publication, with existing certificates requiring registration within 18 months of the module’s entry into force.
- Market Surveillance (MSU) Module: Market surveillance will be managed through this module and reserved for competent authorities.
- Post-Market Surveillance and Vigilance (VGL) Module: This module will be critical for managing reports on serious incidents and corrective actions.
- Clinical Investigations/Performance Studies (CI/PS) Module: Facilitates the management of clinical investigations and performance studies, becoming mandatory six months after notification publication.
Transition and Obligations During the Roll-Out Period
During the transition period, obligations related to Eudamed modules will be gradually enforced, allowing economic operators to adapt to the new requirements without significant disruptions.
Economic operators, such as manufacturers and importers, must ensure that devices are registered in the UDI/DEV module before being placed on the market. Notified bodies, on the other hand, will be responsible for registering and updating certificates, while competent authorities will manage market surveillance data through the MSU module.
Benefits of Eudamed
Eudamed brings numerous benefits, enhancing transparency and traceability in the medical device sector. The platform provides detailed information on devices available on the market, increasing trust among healthcare operators, patients, and regulatory authorities. Furthermore, the integration of modules reduces duplication of efforts, simplifying registration and surveillance procedures.
Another fundamental aspect is the improvement of traceability. Through the UDI/DEV and VGL modules, it is possible to monitor each device throughout its lifecycle, facilitating the management of potential safety or quality issues.
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Source: November 2024, “Gradual roll-out of Eudamed” European Commission
