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Time is running out and May 26th, 2022 will soon be knocking at our doors before we even realize! If you hope to bring your IVD device to the European market you must understand and comply with Annex XIII of IVDR.

This means manufacturers must show evidence that the intended purpose of the IVD device is achieved by providing clinical evidence. Furthermore, the re-classification of IVDs increases this challenge and the race against the clock because many of the devices that did not previously require clinical data to establish safety and efficacy will now be required.

Key Takeaways

  • Definition of a performance evaluation
  • Steps in performance evaluation process
  • How to plan for a performance evaluation
  • Demonstration of the scientific validity and analytical and clinical performance
  • The content of a performance evaluation report