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EU In Vitro Diagnostic Regulation Overview Training (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 IVD, a new risk-based IVD classification system, increased clinical evidence requirements, new quality system mandates, and more rigorous postmarket scrutiny. IVD manufacturers that conduct business in the EU must start their transition to the new regulation now. This course is a critical first step. In this class, you’ll learn about the new requirements found in the IVDR and their impact on manufacturers. We also offer an IVDR auditor class

Compare Classes

We Offer Two EU IVDR Overview Training Classes. Which One is Right for You?

SkillsLab Class ?
DaySmart Class ?

Class Content

In-Depth

Foundational Overview

Class Duration

5 Half-Day Sessions*

6 Hours (One Day)

Teaching Format

Live, Instructor-Led

Live, Instructor-Led

Delivery Options

Virtual or In Person**

Virtual or In Person**

Certification of Completion

Yes

Yes

Continuing Education Units (CEUs)

2.5

0.6

* SkillsLab classes delivered in-person are full-day sessions delivered over 3 consecutive days. 

** Interested in private training for your team, virtually or in-person at your facility? Ask us about it!

Upcoming Classes

Upcoming In Vitro Diagnostic Regulation Training Classes

SkillsLab $3495

There are no public training classes scheduled right now but this class can be delivered privately to 6 or more people at any time. Ask us for details!

DaySmart $995

Course Code Location Class Begins Class Ends Daily Schedule Course Delivery Class Agenda Registration
EVD VIRTUAL DELIVERY (Eastern Time) 17 Jun 2024 17 Jun 2024 10:30AM - 5:30PM Eastern US Time Virtual REGISTER
EVD VIRTUAL DELIVERY (Eastern Time) 15 Jul 2024 15 Jul 2024 10:30AM - 5:30PM Eastern US Time Virtual REGISTER
EVD VIRTUAL DELIVERY (Eastern Time) 09 Oct 2024 09 Oct 2024 10:30AM - 5:30PM Eastern US Time Virtual REGISTER
EVD VIRTUAL DELIVERY (Eastern Time) 03 Dec 2024 03 Dec 2024 10:30AM - 5:30PM Eastern US Time Virtual REGISTER

GROUP DISCOUNT

Save up to

25%

Register 3 people, 4th attends free!

Free

*This offer cannot be combined with any other promotional offer(s).

Course Overview

EU IVDR Training: How Deep Do You Need to Go?

Our DaySmart option provides a foundational overview of the IVDR. You’ll walk away with a solid understanding of the essentials of compliance. Our SkillsLab class goes deeper into more areas of the regulation, with additional hands-on exercises to apply your knowledge. See the table below and choose the option that fits your needs.

 

Course Overview
SkillsLab Class
DaySmart Class

Introduction to the In Vitro Diagnostic Device Regulation (IVDR)

  • IVDR entities, structure
  • Overview of major changes in the IVDR

Quality Management System Requirements

  • QMS roles and responsibilities in the IVDR
Exercise! Identify IVDR QMS Requirements for Manufacturers

Premarket Activities

  • IVDR device classification and classification rules
  • IVDR conformity assessment routes
  • Technical documentation structure and content
  • Role of common specifications (CS) and harmonized standards
  • Technical documentation and the QMS
  • Life-cycle management strategies for technical documentation
Exercise! Classify Devices
Exercise! Determine Technical Documentation Structure

Performance Evaluation

  • Performance evaluation requirements
  • Clinical evidence: role and sources
  • Clinical performance studies under the IVDR
  • Performance evaluation plan (PEP)
  • Performance evaluation report (PER): inputs, content, maintenance
  • Postmarket performance follow-up (PMPF) requirements
Exercise! Linking Clinical Sources, Evidence, and Benefits
Exercise! Identifying Postmarket Data Sources

Unique Device Identification (UDI)

  • IVDR UDI requirements
  • UDI responsibilities; impact on economic operators
  • UDI electronic system and EUDAMED
  • Global impact of UDI systems
Exercise! Determining UDI

Postmarket Activities

  • IVDR postmarket surveillance system requirements
  • Postmarket surveillance reports (PMSRs)
  • Periodic safety update reports (PSURs)
  • Vigilance and trend reporting
  • Technical documentation and postmarket surveillance
  • Role of EUDAMED in vigilance and postmarket surveillance
Exercise! Designing a Postmarket Surveillance Plan

Impact on Auditing

  • IVDR requirements for Notified Bodies
  • How Notified Bodies will conduct IVDR audits
  • Certification process and surveillance audits
  • Role of unannounced audits
  • Impact of Notified Body requirements on internal audit program
Exercise! Identify Potential Nonconformities

Implementing the IVDR

  • IVDR timeline
  • IVDR implementation steps
  • Best practices for planning and implementation
Exercise! Determine IVDR Implementation Responsibilities

Technical Documentation

  • IVDR Annex I General Safety and Performance Requirements (GSPR)
  • Technical documentation structure and content
  • Technical documentation and the QMS roles and responsibilities in the IVDR
Exercise! Identify Impact of GSPR Requirements
Exercise! Determine Technical Documentation Structure
What You Will Learn

What You Will Learn

At the conclusion of this training class, you will be able to
SkillsLab
DaySmart

Describe the structure of the IVDR and identify the key differences between the existing IVDD and the IVDR.

Explain the impact of the new IVDR requirements on economic operators, including manufacturers.

Describe high-level IVDR requirements related to quality management system (QMS), technical documentation and postmarket activities.

Describe the IVDR requirements for Notified Bodies and auditing impact on your organization.

Identify the necessary steps to prepare an organization to implement IVDR requirements.

Understand the IVDR General Safety and Performance Requirements (GSPR) found in Annex 1.

Understand specific IVDR QMS, premarket, technical documentation, performance evaluation, UDI and postmarket requirements.

Who Should Attend

Who Should Attend

Intended for in vitro diagnostic device professionals working for manufacturers, distributors, importers, and other related parties that market (or plan to market) devices in Europe. Designed for professionals in quality and regulatory affairs, as well as personnel involved in design, risk management, postmarket activities, R&D, and manufacturing. The new regulation expands the organization’s quality management system into new functions impacted by the regulatory requirements, such as production and postmarket activities. 

  • RA/QA Professionals
  • Risk Management
  • Production Personnel
  • R&D Engineers
  • Senior Management

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