EUDAMED: The European Database for Medical Devices in Belgium

1. Overview

EUDAMED is the European database for medical devices, structured around six interconnected modules: Actors (identification of economic operators), UDI/Devices (registration of devices with Unique Device Identifier integration), Notified Bodies and Certificates (registration of notified bodies and issued certificates), Clinical Investigations and Performance Studies (registration of clinical trials and performance evaluations), Vigilance and Post-Market Surveillance (handling of post-market surveillance and vigilance reports), and Market Surveillance (coordination of market surveillance activities among competent authorities). Source: https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/generalities/eudamed

2. Purposes

Its purposes include registering actors, devices, certificates, clinical studies, vigilance information, and market surveillance data, with most information in the Actors, UDI/Devices, and Notified Bodies and Certificates modules being publicly accessible, while Clinical Studies, Vigilance, and Market Surveillance modules have limited public access. Source: https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/generalities/eudamed

3. Registration Requirements

Registration requirements vary by module and timeline. Actors (manufacturers, authorized representatives, system or procedure pack producers, importers) must register at T1 (T0 + 6 months, expected Q4 2025), with voluntary registration possible earlier. Device registration (UDI/Devices module) requires associated actors to be registered first; it is voluntary until mandatory actions in the Vigilance module are needed, such as post-market surveillance or vigilance activities (e.g., periodic safety update reports, serious incident reporting, field safety corrective actions). Legacy devices (placed on market post-MDR/IVDR application dates under transitional provisions) and old devices (pre-MDR/IVDR dates) follow similar rules, with registration mandatory only for vigilance-related actions when available. Source: https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/generalities/eudamed

4. Modules in Detail

Actors Module

For identification of economic operators like manufacturers and importers. Mandatory registration at T1. Source: https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/generalities/eudamed

UDI/Devices Module

For device registration integrated with Unique Device Identifiers. Voluntary until needed for vigilance. Source: https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/generalities/eudamed

Notified Bodies and Certificates Module

Registration of notified bodies and certificates. New certificates mandatory at T1; existing ones have 12-month extension post-T1. Source: https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/generalities/eudamed

Clinical Investigations and Performance Studies Module

For registering clinical trials and performance evaluations. Source: https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/generalities/eudamed

Vigilance and Post-Market Surveillance Module

Handles reports of serious incidents, field safety actions, trend reporting, etc. Applicable at T1. Source: https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/generalities/eudamed

Market Surveillance Module

For coordination among competent authorities. Source: https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/generalities/eudamed

5. Timelines

Timelines follow a gradual rollout per Regulation (EU) 2024/1860 amending MDR and IVDR. Modules are audited for functionality, consulted with the Medical Device Coordination Group (MDCG), and declared functional in the EU Official Journal (first modules planned for Q2 2025 as T0). Mandatory use begins six months later (T1), with some extensions to T2 (T0 + 12 months, expected Q2 2026). Actors, UDI/Devices, and Notified Bodies modules have been available voluntarily since 2021. Source: https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/generalities/eudamed

6. Belgian-Specific Aspects

Belgian-specific aspects are not detailed beyond general EU requirements and FAMHP's provision of guidance, such as the Questions and Answers page for actor module registration. Source: https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/generalities/eudamed

7. Conclusion

EUDAMED enhances transparency and coordination in the EU medical device market, with phased implementation to ensure smooth transition.