Comply Guru Worldwide Sites

18hrs Online Course USD $ 1395.00 ★★★★★ 37 Reviews

EU IVDR Training that takes you through the new European In Vitro Diagnostic Regulation (EU IVDR 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.

Why Comply Guru?

  • Exemplar Global Certified
  • Self-Paced, On-Demand Learning (24/7)
  • Highly Interactive, Engaging Experience
  • Industry-leading Methodology
  • Designed by Experts with Proven Expertise
EU IVDR Training for Practitioners

Key Course Information

What you need to know?

Our industry-leading 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.

Available Formats:

eLearning

eLearning

Customized Learning

Customized Learning

Learning Objectives Module Content Who Should Attend? Entry Requirements Assessment Methodology Course Accreditation Technology Requirements

Learning Objectives

On completion of this course, successful Learners will have the knowledge needed to:

  1. Explain the history, purpose, and structure of the EU IVDR and the key terminology used throughout the regulation
  2. Identify the types of the device covered by the EU IVDR, the rules for classification, and the routes to conformity
  3. Describe the obligations of the economic operators and the PRRC
  4. Describe the General Safety & Performance Requirements
  5. Outline the requirements for Performance evaluation and Performance studies
  6. Explain the Post Market Surveillance and Vigilance reporting requirements
  7. Describe the contents of the Technical Documentation and explain the Unique Device Identifier requirements

Module Content

A summary of learning topics within this course include:

  • Purpose of the EU IVDR
  • Structure of EU IVDR
  • Key Terminology
  • EU IVDR v IVDD – Key Changes
  • EU IVDR Timelines for Transition
  • What is an in vitro medical device?
  • Devices in scope
  • Devices out of scope
  • Relationship with Machinery and atomic energy directive
  • Chapter II Terminology
  • Articles 5-9
  • Economic Operator & PRRC Responsibilities
  • Articles 16-21
  • Implementing Rules
  • Classification Rules 1-7
  • Conformity assessment annexes IX, X, XI
  • Article 48 Devices categories and groups
  • Special device conformity
  • Derogation from conformity assessment
  • Notified Bodies
  • Overview of Annex I
  • Chapter I General Requirements
  • Risk Management (ISO 14971)
  • Chapter II Performance, Design & Manufacture
  • Chapter III Device information
  • Articles 56 & 57
  • Performance study articles
  • Annex XIII Part A
  • Annex XIII Part B
  • Annex XIV
  • Summary of safety and performance
  • Post-market surveillance articles 78-81
  • Vigilance terminology
  • Vigilance reporting
  • Trend reporting
  • Analysis of serious incidents and FSCA
  • Data analysis
  • Annex II & III, UDI terminology
  • Annex VI, UDI timelines
  • EUDAMED databases
  • EUDAMED timelines
  • MDCG

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 EU IVDR including but not limited to:

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

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

Assessment Methodology

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

Course Accreditation

Exemplar Global

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

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.

Pricing

Gain an Internationally Accredited EU IVDR Certification

Advance your knowledge and enjoy instant access to your course once you register.

Secure Payment

Individual
USD $ 1395.00
5% Off
Team of 5
USD $ 6625.00
More Than 5?
Contact Sales

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