Watch On-Demand: EUDAMED Compliance with ACKOMAS and EFOR

• EUDAMED is the European database dedicated to medical devices and in vitro diagnostic (IVD) products. It aims to enhance transparency and traceability through Unique Device Identifiers (UDI) for devices within the EU market.
• Compliance with EUDAMED is essential for all manufacturers of medical devices, and registration must be completed by January 2026.

The EUDAMED database consists of six modules, each covering critical areas such as:

• Actors (economic operators)
• Devices (including UDI registration)
• Certificates and notified bodies
• Vigilance and post-market surveillance
• Market surveillance
• Clinical investigations

Currently, only three modules are finalized (Actors, Devices, Certificates), while the others are expected to become mandatory by 2026.

The UDI (Unique Device Identifier) consists of two parts: the UDI-DI for device identification and the UDI-PI for production identification. Each device must have a UDI for traceability. The Basic UDI-DI groups devices under the same family and is a key element required in all technical documentation.

The gradual rollout of EUDAMED means that manufacturers should start registering devices and economic operators as soon as possible. Significant deadlines include Q1-Q3 2025 for module rollout, and full compliance is expected by Q1 2026.

ACKOMAS provides a cloud-based platform that ensures secure, efficient machine-to-machine data synchronization with the EUDAMED database. The platform is designed to facilitate both data creation and modification, offering flexibility and adaptability for different regulatory needs. The solution is fully operational, offering seamless integration and the ability to meet compliance deadlines efficiently.

Manual entry into EUDAMED is time-consuming and complex, especially for companies with a large number of devices or those requiring frequent updates due to regulatory changes. ACKOMAS’ machine-to-machine solution automates much of the process, ensuring faster and more reliable compliance with fewer resources.

Begin registering your economic operators and devices immediately to avoid last-minute delays. Ensure your data repository is ready and that all required information is collected and formatted according to EUDAMED’s specifications.