Which UDI Manager Subscription suits me?

You are a “frequent user” and therefore want more comfort and efficiency in your UDI management. Then the mytracekey UDI Manager FULL is just right for you.

With the mytracekey UDI Manager FULL, we provide you with numerous functions that you need to easily capture, manage, and report your UDI data to EUDAMED. Additionally, you get everything you need to make your quality and UDI management even more efficient and fully compliant.

FULL Features

• All BASIC Features
• Data Volume: 100 UDIs are included in the FULL version; thereafter, the pay-per-use model applies. The full version also adapts flexibly to larger UDI quantities.
• Accounts: Access to the test and production systems, for a maximum of 1 SRN
• Data Management: Manage your UDI data, including all templates (MDR, MDD, IVDR, IVDD)
• Data Import: Import your UDI data as an Excel file; you can also export your data via Excel
• Data Transfer: Data transmission to EUDAMED Playground and Productive (XML bulk upload). The M2M function (direct connection to EUDAMED) can be additionally booked in this package.
• Data Overview: The Task Manager keeps track of your tasks and informs you which UDIs still need to be reported
• Compliance Package: Audit trail and validation documentation, as well as access to the test system, support you in implementing legal requirements for quality assurance and IT security

Pricing

• Contract Duration: Annual contract
• Base Fee: €99/month, annual billing
• Additional Fees: €0.04/UDI for each additional UDI per month