Preparing for EUDAMED: A Guide for Legal Manufacturers

The use of EUDAMED, the European Union's public database for medical devices, will become mandatory in 2026. This comprehensive system encompasses data on economic operators, certificates, vigilance cases, clinical investigations, and more.

To ensure a smooth transition, legal manufacturers are recommended to familiarize themselves with EUDAMED's functionalities and requirements. The European Commission provides a built-in Playground environment (Click Here) where users can explore the system and understand its data dependencies. For instance, once products are registered to an actor, the actor field becomes locked, highlighting the importance of accurate initial data entry.

Here are key steps to prepare for EUDAMED:

• Explore the Playground: Utilize the training environment to navigate the system, simulate data entry, and identify potential challenges.
• Understand Data Dependencies: Recognize how fields interact and the implications of locking mechanisms. This knowledge is crucial for avoiding errors that could complicate future updates.
• Establish Robust Processes: Develop and implement processes to validate data for correctness and completeness before submission. This proactive approach minimizes the risk of additional rework and ensures compliance with regulatory standards.
• Stay Informed: Keep up-to-date with guidance and updates from the European Commission to ensure alignment with the latest requirements. SGS will help you stay abreast of changes and updates.

EUDAMED represents a significant step forward in enhancing transparency and traceability within the medical device industry. By taking these preparatory steps, legal manufacturers can not only ensure compliance but also streamline their operations and contribute to a more efficient regulatory environment.

By: Balázs Bozsik
Business Assurance
Technical Director – Medical Audit, NAM