EUDAMED for medical devices manufacturers 101: preparing for full implementation

The European Database on Medical Devices (EUDAMED) is set to become an essential tool for medical device authorities and manufacturers.?

EUDAMED is a secure, web-based portal provided by the European Commission. It aims to enhance transparency and coordination in the medical devices sector by providing a central point of access for various stakeholders, including manufacturers, EU Authorised Representatives, importers, Notified Bodies and competent authorities.

Originally proposed several years ago, its implementation has faced multiple delays. However, recent updates provide clarity on the final implementation dates that all companies selling medical devices into the EU must be aware of. The lates public plan from the European Commission outlines the roadmap for release of EUDAMED’s full functionality, marking crucial dates for manufacturers and other stakeholders where EUDAMED use moves from voluntary to legally required.

For manufacturers, especially those with extensive and complex product portfolios, preparing for EUDAMED’s requirements involves several critical steps:?

• Understanding UDI requirements
• Collecting and managing UDI data
• Planning for data upload?

The forthcoming implementation of EUDAMED represents a significant milestone for the EU medical device market. Manufacturers must take proactive steps to ensure they are prepared for these changes. By understanding the requirements, collecting and managing UDI data effectively, and planning for compliance, manufacturers can navigate this transition smoothly and continue to provide safe, effective medical devices to the European market.

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