We are so proud to announce that after the initial round of EUDAMED Playground M2M Data Exchange testing, Innovit was the only solution provider able to successfully complete all the test cases for Device/UDI Registration. Those test results were published by the EU Commission Data Exchange Workgroup on Oct 3rd. Based on these initial findings, MedTech Europe requested that we provide a summary of test results, and recommendations to the EU Commission.

 

Here is a summary of the test results Innovit provided after initial rounds of testing:

M2M Test Case Summary for Device/UDI Registration

  • MDR –  Positive Scenarios
    • 11 of 15  successfully completed
    • 2 confirmed to be invalid scenarios or not yet supported by EUDAMED Support
    • 2 in progress (awaiting response from EUDAMED support)
  • MDR  –  Negative Scenarios
    • 2 of 7 successfully completed
    • 3 confirmed to be invalid scenarios or not yet supported by EUDAMED Support
    • 1 fail (only partial fix available and awaiting for full fix before retesting)
    • 1 in progress (awaiting response from EUDAMED support)
  • IVDR – Positive Scenarios
    • 5 of 7 successfully completed
    • 2 confirmed to be invalid scenarios or not yet supported by EUDAMED Support
  • IVDR –  Negative Scenarios
    • 2 of 2 successfully completed

 

Today, Innovit is leading the charge for a comprehensive M2M EUDAMED Compliance solution and we look forward to working alongside other MedTech Europe members to continue testing EUDAMED data exchange and providing valuable feedback to the European Commission!