EU MDR Training for Practitioners that takes you through the new European Medical Device Regulation (2017/745), not just from an industry perspective, but also from a Notified Body perspective. This course 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 & pace that works best for you, making it easier to get the training you need while balancing a busy home or work life.

Why Comply Guru?

  • CQI & IRCA + Exemplar Global Certified Training (No. 2378)
  • Self-Paced, On-Demand Learning (24/7)
  • Highly Interactive, Engaging Experience
  • Industry-leading Methodology
  • Designed by Experts with Proven Expertise
Course Snapshot
Accreditation
CQI & IRCA (No. 2378), Exemplar Global
Duration
20hrs
Available Format
eLearning
Price
USD $  1195.00
Learner Rating
★★★★★ 303 Reviews

Course Overview

EU MDR Training for Practitioners

Learning Objectives Covered

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

Identify the types of devices covered by the EU MDR and the rules for classifying these devices

Describe the obligations of the economic operators and the PRRC

Describe the General Safety & Performance Requirements and the key features of a risk management system based on ISO 14971

Describe the contents of the Technical Documentation and the requirements for Post Market Surveillance, Vigilance, and Clinical Data

Explain the Unique Device Identifier requirements and the relationship with EUDAMED

What This Course Covers Covered

Introduction to the EU MDR

  • History, Purpose & Structure of the EU MDR
  • Key Terminology
  • Key EU MDR changes
  • EU MDR Timelines for Transition

Medical Devices covered by the EU MDR

  • What is a device?
  • Devices in & out of scope
  • Relationship with other Directives
  • Legacy Devices

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 17-20
  • Articles 21-24

Device Classification

  • Types of Risk Class
  • Duration of Use
  • Types of Body Contact
  • Principles of Classification
  • Continuous Use
  • Classification Rules
  • Non-Invasive Rules 1-4
  • Invasive Rules 5-8
  • Active Devices Rules 9-13
  • Special Classification Rules

Routes to Conformity

  • Overview of Conformity Assessment
  • Annex IX Overview including Chapters 1-2
  • QMS: Additional MDR Requirements
  • Annex X Type Examination
  • Annex XI Product Conformity Verification
  • 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 Evaluation

  • Clinical Evaluation Introduction
  • Article 61 Exemption and Update
  • Annex XIV Part A: Clinical Evaluation and Part B: PMCF
  • Summary of Safety & Clinical Performance (SSCP)
  • Clinical Evidence for Legacy Devices
  • Clinical Data Requirements

Post Market Surveillance and Vigilance

  • Chapter VII Post Market Surveillance
  • Vigilance Terminology & Reporting
  • Trend Reporting
  • Article 89
  • Additional Considerations
  • 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 has been designed for those working in Quality Assurance and/or Regulatory Affairs who want to gain a better understanding of the EU Medical Device Regulation (EU MDR 2017/745), including:

  • Quality Assurance Professionals
  • Quality Engineers
  • Research and Design Engineers
  • Internal Auditors
  • Quality Managers
  • Manufacturing Engineers
  • Regulatory professionals
Course Accreditation & Certificate

CQI IRCA
CQI & IRCA certify this course (No. 2378). Upon successful completion, each Learner shall receive a digital Certificate of Achievement within 1 business day.

What Are The Entry Requirements

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

  • A working knowledge of ISO 13485, which may be gained by completing Comply Guru’s ISO 13485 Foundation Course
  • The relationship between ISO 13485 and the EU MDR 2017/745
  • Commonly used quality management terms and definitions within ISO 13485 and ISO 9000
  • 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 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.

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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