Our Guide to Find the Best Fit

You would like to book the mytracekey UDI Manager but are unsure which package best suits your needs? We are happy to help you find the right package. Therefore, we have detailed and compared the individual packages below to make your decision easier.

We offer five different variants so that every company can find a suitable UDI Manager.

FREE: Free trial version

BASIC: Flexible entry-level package

FULL: Full scope of functions

PREMIUM: Extended range of functions

ENTERPRISE: Large UDI volumes

mytracekey UDI Manager FREE

The trial version allows you to try out the functions of the software yourself and find out whether the requirements are met. You can easily switch to a higher category from this version. The data you have already entered will be retained.

FREE Features

  • Data Volume: 10 UDIs are included in the FREE version
  • Accounts: Access to the test system, for a maximum of 1 SRN
  • Data Management: Manage your UDI data, including all templates (MDR, MDD, IVDR, IVDD, AIMDD)
  • Data Import: Import your UDI data as an Excel file
  • Data Validation: Check your UDI data for completeness (EUDAMED Business Rules Check)
  • Data Transfer: Data transmission to EUDAMED Playground (XML bulk upload)
  • Onboarding: Comprehensive documentation package within the mytracekey Self Service Portal, including training documents and FAQs
  • Requirements: No IT infrastructure or prior knowledge required

Pricing

  • Contract Duration: –
  • Base Fee: –
  • Additional Fees: Limited range of functions

mytracekey UDI Manager BASIC

Our entry-level package with which you can easily record, manage and report your UDI data to EUDAMED. Perfect for small companies with a low UDI volume that do not want to do without the convenience and security of a centralised solution for their master data management.

BASIC Features

  • Data Volume: 100 UDIs are included in the BASIC version; after that, the pay-per-use model applies. This makes the BASIC version ideal for small UDI volumes
  • Accounts: Access to the production system, for a maximum of 1 SRN
  • Data Management: Manage your UDI data, including all templates (MDR, MDD, IVDR, IVDD, AIMDD)
  • Data Import: Import your UDI data as an Excel file
  • Data Validation: Check your UDI data for completeness (EUDAMED Business Rules Check)
  • Data Transfer: Data transmission to EUDAMED Productive (XML bulk upload)
  • Onboarding: Comprehensive documentation package within the mytracekey Self Service Portal, including training documents and FAQs
  • Requirements: No IT infrastructure or prior knowledge required.

Pricing

  • Contract Duration: Monthly contract term
  • Base Fee: €79/month
  • Additional Fees: €0.48/UDI for each additional UDI per month

mytracekey UDI Manager FULL

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

mytracekey UDI Manager PREMIUM

Do you have multiple business units (SRN) and want to use M2M for data transmission to EUDAMED? Then our Premium package is perfect for you.

PREMIUM Features

  • All FULL features
  • Data Volume: 300 UDIs are included in the PREMIUM version; thereafter, the pay-per-use model applies.
  • Accounts: Access to the test and production systems, for a maximum of 3 SRN
  • Data Transfer: Data transmission to EUDAMED Playground and Productive (XML bulk upload and M2M are inclusive)

Pricing

  • Contract Duration: Annual contract
  • Base Fee: €179/month, annual billing
  • Additional Fees: €0.04/UDI for each additional UDI per month

mytracekey UDI Manager ENTERPRISE

The ENTERPRISE package is ideal for those seeking a long-term, strategic partnership while managing over 3,000 UDIs.

ENTERPRISE Features

  • ALL PREMIUM Features
  • Data Volume: starting from 3.000 UDIs (included)
  • Onboarding: In addition to the comprehensive self-service portal, ENTERPRISE provides you with extended support and additional user training

Pricing: On request

Add-On: M2M – The Direct Wire to EUDAMED

If you need even more advanced UDI management, consider adding the M2M function. This interface between EUDAMED and the mytracekey UDI Manager provides maximum convenience, enabling you to manage all your UDI tasks within the mytracekey software.

The M2M (Machine-to-Machine) interface directly connects mytracekey with EUDAMED. This direct link enhances quality management by securely transmitting data and automatically creating a comprehensive audit trail with version control. It also allows for faster reporting of large UDI volumes to EUDAMED.

[M2M can be optionally added to mytracekey UDI Manager FULL; in PREMIUM and ENTERPRISE it is included]

M2M Features

  • Data Transfer: With the direct connection to EUDAMED, you can exchange data with EUDAMED at any time without limits
  • Compliance: All data transmissions to EUDAMED are visible in the UDI Manager. Ideal for providing proof of data transmission to EUDAMED (e.g., during audits or upon request from authorities)
  • Requirements: Active mytracekey UDI Manager FULL subscription

Pricing

  • Contract Duration: Monthly contract term
  • Base Fee: €50/month
  • Additional Fees: –