To interact with any EUDAMED module, your company must first obtain a Single Registration Number (SRN) via the electronic system. The SRN is issued by the relevant competent authority after validating your company and Authorised Representative details. This number is essential for accessing Notified Bodies, conformity assessments, and completing any future regulatory submissions.

Beyond operator registration, manufacturers must submit complete UDI data, including the Basic UDI-DI, into the EUDAMED UDI database. This ensures full traceability of medical devices across the EU supply chain. Our service guarantees your UDI submissions align with labeling requirements and are correctly mapped in the database—preventing costly compliance gaps.

EUDAMED is not a one-time task. Manufacturers must verify and confirm their operator data at least once every two years. You’re also required to update the Summary of Safety and Clinical Performance (SSCP), maintain visibility in the vigilance module, and report serious incidents to ensure timely post-market surveillance and corrective action.

We provide ongoing support to ensure your EUDAMED access, UDI submissions, SRN management, and AR representation remain valid and compliant—giving you peace of mind and uninterrupted access to the European market.