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

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.

Course Days

Virtual Class Days: 5 days, daily 1:00  - 5:00 PM EST

Related Courses

EU IVDR Related

• New! EU IVDR Auditor Training (Europe’s Medical Device Regulation 2017/746)
• Implementing the EU’s New Medical Device Regulation (MDR 2017/745)

EU MDR Related

• EU MDR Auditor Training (Europe’s Medical Device Regulation 2017/745)

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: