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Performance Evaluation Report (PER) Training for EU IVDR Compliance

Learn what you need to put in your performance evaluation reports so that your in vitro diagnostic device can enter the EU market.

Article 56 of the new In Vitro Diagnostics Regulation (EU IVDR) requires any in vitro diagnostic device that would be placed on the EU market to have a performance evaluation report. This report is comprised of the clinical evidence (including your scientific validity report, analytical performance report, and clinical performance report) that demonstrates that your IVD fulfills its intended purpose and is both safe and effective. In this interactive foundational class, your instructor will cover the basic skills and knowledge you will need to design and modify performance evaluation plans (PEPs) and execute on performance evaluation reports (PERs).

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Course Details

What Will You Learn

At the end of this workshop, you will be able to:

  • Describe the requirements of performance evaluation reports in the EU.
  • Define clinical evidence, claims, and intended purpose statements and their relationship with each other.
  • Describe performance evaluation plans and how they relate to performance evaluation reports.
  • Describe the purpose of the scientific validity report and the information that should be included in it.
  • Describe the objective of the analytical performance report and the data required to substantiate conclusions.
  • Describe the purpose of the clinical performance report and the conclusions that can be drawn from it.
  • Identify sources of clinical literature, search criteria, and state of the art with linkage to the PER.
  • Explain equivalent device data and when it can be used.
  • Demonstrate how data is appraised and analyzed, and the summarization of safety and performance.
  • Discuss the benefit-risk analysis and how ISO 14971 is relevant to PERs.
  • Explain postmarket surveillance and its relevance to PERs.
  • Describe postmarket performance follow-up, procedures for collecting data, and the rationale for when it is needed.
  • Illustrate the life-cycle approach to PERs and postmarket performance follow-up (PMPF).
  • Define the characteristics of the PER’s summary and conclusion sections and the rationale for when updates may be made to PERs.

Who Should Attend

This course is appropriate for anyone working in regulatory, quality, postmarket surveillance, marketing, R&D, medical/clinical affairs, and those who need to create, review, and audit performance evaluation reports.

  • Virtual Half-Days

  • In-Person Full-Days

  • CEUs


Virtual Session Details

Virtual Session Details

Oriel STAT A MATRIX virtual instructor-led training (VILT) is a real-time internet-based learning experience where the instructor and learners are in separate locations. Oriel STAT A MATRIX’s VILT technology platform is designed to simulate a traditional in-person classroom experience and allows for 2-way dialogue, break-out sessions for engaged workshops and hands-on exercises, and group work using virtual breakout rooms. This provides for an engaging learning experience in which participants can connect with the content and interact with both the instructor and other classmates.

The learning objectives and topics covered during VILT are the same as those for the in-person version of the course. To accommodate the VILT format, classes are delivered at a pace well suited to virtual instruction, and the structure of class workshops and exercises has been modified to work best in the virtual environment.

Online Training Schedule

This class is delivered across 5 consecutive days. Sessions run daily from 1:00-5:00 p.m. (Eastern Time).

Technical /Logistical Requirements

To participate in this learning, first and foremost, we need your engagement!  You will also need:

  • PC MAC Computer

    PC or MAC Computer

  • Reliable Internet

    Reliable Internet

  • Video Webcam

    Video Webcam

  • Headset or Earbuds

    Headset or Earbuds

  • Quiet Setting

    Quiet Setting

  • Two Monitors Recommended

    Two Monitors

See course dates to find / register for a virtual online session of this course.

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Virtual Session Details

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