EUDAMED

The European Database of Medical Devices (EUDAMED) will be gradually rolled out from 2025, and registering medical devices product in the database is currently scheduled to become mandatory from 2026.

This process is meant to ensure traceability of medical devices in the EU market, and MedTech and Pharma companies will therefore be required to submit all relevant information about their products after this deadline.

For many companies, gathering the necessary information and submitting the relevant data for EUDAMED is a complex and time-consuming task. Our regulatory affair specialists can assist with this process and e.g. help clarify, whether your organization needs a digital platform for automating the process of uploading device data to the EUDAMED database.