Basel, Switzerland – We at Europe IT Consulting GmbH are thrilled to announce a significant milestone in our ongoing efforts to support medical device manufacturers with compliance and regulatory requirements. We have successfully transferred over 107,000 UDI-DI records to the European Database on Medical Devices (EUDAMED). This achievement marks a critical step in ensuring the traceability and safety of medical devices across Europe.
The process of transferring UDI-DI data to EUDAMED is complex and meticulous, requiring precision and adherence to stringent regulatory standards. We are at the forefront of this initiative, providing our clients with seamless and efficient solutions for data submission.
Our Global UDI Add-On for SAP has been instrumental in managing and maintaining UDI attributes, facilitating the digital transfer of data to EUDAMED.
Impressive Statistics:
- 107,000 UDI-DI Records Transferred: We have efficiently transferred a vast number of UDI-DI records, showcasing our capability to handle large-scale data submissions.
- Association with Basic UDI-DI: Typically, the number of UDI-DIs associated with a single Basic UDI-DI ranges between 11 and 550. However, there have been notable instances where a single Basic UDI-DI has been linked to over 1,600 UDI-DIs, demonstrating the variability and complexity of device registrations.
Our successful implementation of UDI submissions to EUDAMED underscores our commitment to excellence and our role as a leader in the field of medical device compliance. This accomplishment highlights not only our technical prowess but also our dedication to enhancing patient safety through improved traceability of medical devices.
About EUDAMED: EUDAMED is a critical component of the European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). It aims to enhance transparency and coordination of information on medical devices available in the EU market. The database includes several interconnected modules, including UDI/Devices Registration and Notified Bodies and Certificates, which are essential for the full functionality and regulatory compliance of medical devices in Europe.
For more information about our services and our Global UDI Add-On solution, visit Europe IT Consulting GmbH.
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