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Enroll three students in the same course (held on the same date and at the same location) at the regular price and receive a fourth enrollment for free. *This offer cannot be combined with any other promotional offer(s).


EU IVDD to IVDR Transition Training (EU IVDR (2017/746))

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 now in order to meet the May 26, 2022 transition 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 transition to the IVDR.

Upcoming Dates and Locations

Please Contact Us if you need additional information or if you don't see a date that works for you. To register by phone, call 1.800.472.6477  |  Private training available, learn more »

Location Start Date Days Cost Public Course Private
VIRTUAL DELIVERY (PM) 06/01/2020 5 $3195.00 Add to Cart CONTACT US
Raleigh, NC 07/08/2020 3 $3195.00 Add to Cart CONTACT US
San Francisco Area, CA 07/21/2020 3 $3195.00 Add to Cart CONTACT US
Chicago, IL 07/28/2020 3 $3195.00 Add to Cart CONTACT US
Edison, NJ 08/11/2020 3 $3195.00 Add to Cart CONTACT US
Austin, TX 08/25/2020 3 $3195.00 Add to Cart CONTACT US
San Diego, CA 09/08/2020 3 $3195.00 Add to Cart CONTACT US
Orlando, FL 09/22/2020 3 $3195.00 Add to Cart CONTACT US

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.

In-Person Days: 3
CEUs: 2.5

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 3.5 hours sessions.  Each session is a combination of subject matter expert and group discussions, interactive whiteboards, polls, and chat rooms that help students with small group exercises, making this an engaging, interactive learning experience.

A typical public seminar schedule for this class would run:

  • Monday 1:30 PM – 5:00 PM
  • Tuesday 1:30 PM – 5:00 PM
  • Wednesday 1:30 PM – 5:00 PM
  • Thursday 1:30 PM – 5:00 PM
  • Friday 1:30 PM – 5:00 PM

Public seminars are run on the eastern time zone to allow for attendance by west coast attendees. Additional sessions may be offered in other time zones.

We may also from time to time offer sessions that run daily from 8:30 AM to 12:00 PM.

Technical /Logistical Requirements

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

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

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The dates you choose. The location you want.
The results you need!

Bring any of our classes to your location - Oriel STAT A MATRIX Private training is the perfect solution for training groups of five or more employees or launching a companywide training effort. It's cost-effective, completely customizable, and absolutely hassle-free. For more information, call 1.800.472.6477 or Contact Us.

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