Effectively Meeting the New EUDAMED Compliance Deadline Published on July 23, 2024, by Patrick RENARD on Devicemed.fr
The EUDAMED compliance deadline set for January 1, 2026, presents a significant challenge for medical device manufacturers. Adopted on April 24, 2024, the latest amendment to regulations (EU) 2017/745 and 2017/746 mandates the use of several EUDAMED modules, with severe consequences for non-compliance. Nicolas Blanquet, Managing Director of Ackomas, explains how this database, designed to enhance transparency and traceability of medical devices within Europe, centralizes crucial information for patient safety and business viability.
Manufacturers must undertake meticulous preparation, analyzing their regulatory position, assessing risks, and structuring their data to ensure effective synchronization with EUDAMED. Product coding through Unique Device Identifiers (UDI) and the use of suitable software are essential for managing data and maintaining compliance. Ackomas offers an integrated software solution to facilitate this management, ensuring continuous traceability and synchronization while reducing the risk of errors.
By actively preparing, companies can transform this regulatory obligation into an improvement opportunity, enhancing their operational efficiency and responsiveness in the European medical device market. This collective effort can ultimately contribute to better patient safety and increased confidence in the medical devices marketed in Europe.
