EUDAMED Registration
Expert EUDAMED Registration & Management Services
Seamlessly Navigate the EU's Medical Device Database, Ensuring Full MDR & IVDR Compliance and Uninterrupted Market Access.
Compliance with the European medical device framework is intrinsically linked to the EUDAMED database. This centralized system is the cornerstone of the EU’s commitment to transparency, traceability, and market surveillance. For non-EU manufacturers, accurate and timely management of EUDAMED is not just a regulatory task—it is a mandatory requirement for maintaining market access.
At Aequum, our team of qualified representatives specializes in managing the complexities of the EUDAMED system. We provide comprehensive, hands-on services that cover every aspect of your registration and ongoing compliance obligations, allowing you to focus on innovation and commercial growth while we handle the intricate data management.
Our EUDAMED Services & Key Benefits:
Seamless Actor & Device Registration (SRN/UDI) We manage the entire registration process from the very beginning. This includes registering you as an "Actor" in the system to obtain your crucial Single Registration Number (SRN). Following this, we handle the meticulous submission of all UDI/Device information, ensuring every product you place on the market is correctly and compliantly registered.
Proactive Compliance & Regulatory Monitoring EUDAMED is a dynamic system with evolving requirements. Our service extends beyond initial registration. We proactively monitor for regulatory changes, system updates, and new guidance from European authorities. This ensures your submissions and records are always aligned with the latest compliance needs, protecting you from potential issues.
Expert MDR & IVDR Data Submission Our team possesses an in-depth, practical understanding of the specific data requirements under both the MDR and IVDR. We expertly manage the submission of all necessary documentation, including linking devices to their relevant notified body certificates and ensuring all data fields are populated accurately and efficiently.
Ongoing Data Management & Vigilance Reporting We provide continuous oversight of your device data within EUDAMED, performing updates as needed to reflect any changes. Furthermore, we support you in fulfilling your post-market obligations by assisting with the submission of vigilance data and other post-market surveillance reports through the platform, ensuring a complete and compliant data footprint.
Partner with Aequum to transform EUDAMED from a complex administrative burden into a seamlessly managed component of your European compliance strategy.