The European Commission has confirmed that key EUDAMED modules will become mandatory by Q3 2026 and manufacturers selling into the EU need to be ready. This article outlines five key reasons to prioritize EUDAMED registration now to avoid disruption, ensure compliance, and maintain market access.
After years of delay, the European Database on Medical Devices (EUDAMED) is here. The system is steadily moving toward full implementation and, by late 2026, core components will be mandatory for all manufacturers selling medical devices in the EU. If you haven’t started the registration process yet, now is the time. Registering in EUDAMED ahead of the deadline can ensure your products remain visible, traceable, and eligible for sale across Member States. Here are five reasons to register in EUDAMED today.
In June 2024, the European Commission outlined a gradual roll-out plan for EUDAMED via Regulation (EU) 2024/1860. This moved up mandatory EUDAMED registration significantly, as the incremental approach allows each module to become mandatory upon its official declaration of functionality, without waiting for completion of all modules.
(source: Overview - European Commission)
Only the Actor Registration, UDI/Device Registration, and Notified Bodies and Certificates modules are currently operational and will become mandatory from Q3 of 2026. Manufacturers need to act fast to implement work instructions on how to register their devices in EUDAMED and conduct the registrations. Early registration also demonstrates proactive compliance and ensures you’re ready for the full functionality of EUDAMED.
EUDAMED will become essential for assigning and managing your UDI-DI and UDI-PI data. Without registration, your devices may not meet the required traceability requirements as per MDR and IVDR, which are critical for patient safety and regulatory audits. It is crucial to note that the UDI-DI structure must follow strict formats and include detailed information about the device’s model, version, and other attributes, such that it can uniquely distinguish the device. Ensuring accuracy and consistency across all data fields can be technically challenging and demanding. Although the transitional timelines for legacy devices apply, Manufacturers are advised to start adhering to UDI requirements as soon as possible.
Data quality in EUDAMED is critical for upholding transparency, traceability, and patient safety across the EU market. All information submitted in EUDAMED is public and will be stored even though new revisions may be uploaded. Therefore, poor data quality is not only a technical problem for the Manufacturer, but a regulatory and business risk as well. Manufacturers should review their data, make sure it follows the applicable Regulation(s), and is up to date before EUDAMED submission.
EUDAMED registration ensures that your products are visible and approved for sale across the EU market as Member States shift away from national databases. Although UDI/Device Registration is not mandatory until Q3 of 2026, some Member States are already encouraging Manufacturers to register their devices in EUDAMED, instead of national databases, for better traceability, transparency, and data harmonization.
The broader healthcare industry is also embracing EUDAMED as a critical resource. Some distributors and healthcare facilities have started using EUDAMED as a catalogue reference for purchasing medical devices from Manufacturers. In some cases, distributors have started refusing devices unless they are registered in EUDAMED, which signals UDI/Device Registration is already a business imperative.
GUDID (Global Unique Device Identification Database) registration in the US provides a structured foundation of device identification data that can be adapted to European requirements. Since GUDID and EUDAMED require similar core information, such as device identifiers, manufacturer details, and device description, having device(s) already listed in GUDID means that much of the necessary data has been collected, standardized, and validated. This can streamline the preparation and submission process for EUDAMED, reducing duplicate effort and minimizing the risk of inconsistencies. In short, if you are already familiar with GUDID, you’re a step ahead.
EUDAMED is not just another regulatory hurdle: it's an opportunity to improve transparency, harmonize market access, and strengthen device traceability across the EU. With 2026 fast approaching and more stakeholders expecting EUDAMED registration, there’s no time to wait.
Pure Global can provide comprehensive support throughout the registration process. Our team of regulatory specialists is highly experienced in working with EUDAMED and can assist you in navigating its modules with confidence and precision. We offer tailored guidance to ensure your devices are registered efficiently, accurately, and in full compliance with EU regulations. Contact us to learn how we can help you get started with EUDAMED.
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