EU IVDR Training that takes you through the new European In Vitro Diagnostic Regulation (2017/746), not just from an industry perspective, but also from a Notified Body perspective. It has been specifically designed for Quality & Regulatory Professionals who are new to the Regulation.

Our online training is a highly interactive way to learn at a time & a pace that works best for you, making it easier to get the training you need while balancing a busy home or work life.

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Course Access for 6 Months
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Course Snapshot
Accreditation
Exemplar Global
Duration
24hrs
Available Format
eLearning
Price
USD $  1495.00
Learner Rating
★★★★★ 55 Reviews
Why Choose Comply Guru?
Globally Recognized Qualification
Learn Anywhere, Anytime
Course Access for 6 Months
Ask The Instructor
Minimize Downtime at Work
Quick Enrolment within 1hr
Scalable Learning for Teams
Manager Accounts for Groups of 10+

Course Overview

EU IVDR Training for Practitioners

Learning Objectives Covered

Explain the history, purpose, and structure of the EU IVDR and the key terminology used throughout the regulation

Identify the types of the device covered by the EU IVDR, the rules for classification, and the routes to conformity

Describe the obligations of the economic operators and the PRRC

Describe the General Safety & Performance Requirements

Outline the requirements for Performance evaluation and Performance studies

Explain the Post Market Surveillance and Vigilance reporting requirements

Describe the contents of the Technical Documentation and explain the Unique Device Identifier requirements

What This Course Covers Covered

Introduction to the EU IVDR

  • Purpose of the EU IVDR
  • Structure of EU IVDR
  • Key Terminology
  • EU IVDR v IVDD – Key Changes
  • EU IVDR Timelines for Transition

Medical Devices covered by the EU IVDR

  • What is an in vitro medical device?
  • Intended Purpose
  • Devices in scope
  • Devices out of scope
  • Relationship with other Directives

Placing a Device on the Market

  • Overview of Chapter II
  • Articles 5-9
  • Articles 10-16
  • Manufacturer Obligations
  • Authorized Representative
  • Importer & Distributor Obligations
  • Person Responsible for Regulatory Compliance (PRRC)
  • Articles 17-21

Device Classification

  • Principles of Classification
  • Implementing Rules
  • Continuous Use
  • Classification Rules
  • General Requirements for All Risk Classes
  • Classification & Intended Use

Routes to Conformity

  • Overview of Conformity Assessment
  • Annex IX Overview including Chapters 1-3
  • QMS: Additional MDR Requirements
  • Annex X Type Examination
  • Annex XI Production Quality Assurance
  • Conformity Assessment of Device Class
  • Special Device Conformity
  • Derogation from Device Conformity
  • Notified Bodies

GSPR and Risk Management

  • Chapter I General Requirements
  • Risk Management
  • Chapter II Design & Manufacture
  • Chapter III Device Information

Clinical Evidence, Performance Evaluation & Performance Studies

  • Performance Evaluation Introduction
  • Clinical Evidence
  • Annex XIII Part A – Scientific Validity
  • Analytical and Clinical Performance
  • Clinical Performance Studies
  • Post Market Phase
  • Performance Evaluation Report

Post Market Surveillance and Vigilance

  • Chapter VII Post Market Surveillance
  • Vigilance Terminology & Reporting
  • Trend Reporting
  • Article 89
  • Additional Considerations
  • IVD Medical Device Documentation

Technical Documentation, UDI and EUDAMED

  • Annex II & III: Technical Documentation
  • UDI Requirements & Timelines
  • EUDAMED
  • MDCG Guidance Documents
Who Should Attend

This course is aimed at anyone working in the in-vitro diagnostic medical device sector who is responsible for or involved in ensuring compliance to the EU IVDR 2017/746 including but not limited to:

  • Regulatory affairs
  • Design and development
  • Quality Management/Assurance
  • Quality Engineers
  • Internal Auditors
  • Authorized Representatives
  • PRRCs
Course Accreditation & Certificate

Exemplar Global certifies our Comprehensive EU IVDR Training for Practitioners Course. Successful completion will entitle each Learner to receive a digital Certificate of Achievement.

What Are The Entry Requirements

Before completing this course, each Learner should have the following prior knowledge:

  •  Knowledge of the requirements of ISO 13485, which may be gained by completing a CQI and IRCA Certified MD-QMS ISO 13485 Foundation (FD132) training course or equivalent.
  • The relationship between ISO 13485 and the EU IVDR 2017 746
  • Commonly used quality management terms and definitions within ISO 13485
  • A working knowledge of risk management principles related to the design of a medical device, through ISO 14971
How Will You Be Assessed

In order to successfully complete this course, each Learner will need to:

  • Complete all the eLearning modules and obtain 70% or higher in the final assessments (MCQ-based) within the 90-day course license
What Are The Technology Requirements

There are recommended requirements for each Learner in wishing to complete any of our eLearning modules. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well. Read the full technology requirements here.

About Our EU IVDR Training for Practitioners

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Frequently Asked Questions

Yes, we permit substitutions provided the license has not been activated and this is requested within 30-days of the purchase date. There is no fee for substitutions.
Yes, we offer discounts. The first discount will apply for an order of 5 licenses (Team of 5). If you need more licenses, complete the request quote form as the discount will be applied based on the exact number of licenses required.
This course duration provided is an estimate based on a standard formula for the time it will take an average Learner. The precise amount of time it takes to complete the course will vary depending on your prior experience & learning style.
The standard license is for 90 days (3 months). Access is available 24/7 for the full 90-days even if you complete the course, you can still go back in and view the course content, but you cannot retake the assessments.
Each Learner is provided with 3 attempts at each final assessment. We strongly encourage all Learners to review the course content again before each attempt (if unsuccessful on an attempt). If unsuccessful after a 3rd attempt, a new course license is required (fee applies).
The fastest and easiest way to pay would be to use your credit card. If you cannot do that, and you require a PO, please email our team at training@complyguru.com
There are recommended requirements for each Learner in wishing to complete any of our eLearning modules. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well. Read the full technology requirements here.
Once you have completed the final assessments, your certificate will be available within 1 business day via your Dashboard. To access your certificate, you must first submit a short course survey and then the certificate will be available for download/print.
CQI & IRCA Accredited Training Provider

CQI & IRCA Accredited Training Provider

Offering certified courses since 2019

Exemplar Global Recognized Training Provider

Exemplar Global Recognized Training Provider

Offering certified courses since 2020