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Implementing the EU's New In Vitro Diagnostic Regulation Training Course (IVDR 2017/746)

This class is for medical device professionals who need get a foundation in the EU IVD Regulation. If you are an experienced auditor and need to learn how to perform audits to the EU IVDR requirements, choose our EU IVDR Auditor Training class.

The changes under Europe’s new IVD regulation are significant, including the need for Notified Body involvement, a greatly expanded definition of what is considered an IVDR, a new risk-based IVD classification system, increased clinical evidence requirements, new quality system mandates,  and more rigorous postmarket scrutiny.

IVD manufacturers who conduct business in the EU must start their transition or implementation of the new regulation now in order to meet the May 26, 2022 deadline. This course is a critical first step. In this class you’ll learn about the significant new requirements found in the IVDR, their impact on manufacturers, and how to plan an effective and efficient implementation of to the IVDR.

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Course Detail

What You Will Learn

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

  • Describe IVDR objectives and structure, and identify key differences between the IVDD and IVDR.
  • Explain the impact of the new IVDR requirements on economic operators, including manufacturers.
  • Describe the various regulatory requirements through the life cycle of a device (e.g., premarket, design and development, product realization, and postmarket).
  • Explain new stipulations for the clinical evaluation process and risk management, including performance evaluation.
  • Understand new device classification rules plus technical documentation, UDI, and traceability specifications.
  • Articulate postmarket surveillance and reporting mandates in the IVDR.
  • Identify the steps needed to prepare an organization to transition to the IVDR.
  • Plan a gap assessment to transition an organization to compliance and understand the impact on internal auditing.

Who Should Attend

Anyone who works for manufacturers that market in vitro diagnostics in the EU.

  • Virtual Half-Days

    5
  • In-Person Full-Days

    3
  • CEUs

    2.5

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.

Training Schedule

  • This training is delivered as five consecutive half-day sessions.
  • Daily sessions run from 1:00-5:00 p.m. Eastern time.
  • This convenient half-day format allows you to balance your other responsibilities while still getting the training you need. 
  • See upcoming sessions of this class.

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

Virtual Session Details

Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

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