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EU MDR Training for Practitioners working with the European Medical Device Regulation (2017/745)

4.6 ★★★★★ 333 Reviews 97% Recommended from 5K+ Learners

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.

CQI & IRCA certify this course (No. 2378)  and the Regulatory Affairs Professionals Society recognize this course where members will be eligible for RAPS credits (12).

CQI-IRCA Cretified Course RAPS Cretified Course
EU MDR Training for Practitioners working with the European Medical Device Regulation (2017/745)
 
Course Snapshot
Approved By
CQI & IRCA (No. 2378) and the Regulatory Affairs Professionals Society (RAPS)
RAPS Credits
12
Duration
24hrs
Teaching Format
eLearning
Certification of Completion
Yes
Language (s)
English
Individual Price
€895.00
Learner Rating
4.6 ★★★★★ 333 Reviews

Have 5 or more that need training?

We offer group discounts and are available for in-house (live or virtual) or tailored training in multiple formats.

How Skeletal Dynamics switched to Online Learning & saved 50% on MedTech QARA Training

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“Over the years, I have used many well-known U.S training providers, but I found Comply Guru had truly mastered ‘online’ training which has saved Skeletal Dynamics over 50% in training fees, associated expenses as well as 100% of the time lost spent travelling to training with other providers.”
Mario Arbesu

Mario Arbesu

VP of Quality Assurance & Regulatory Affairs

How TÜV SÜD utilized eLearning & saved 40% on Lead Auditor Training

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How TÜV SÜD utilized eLearning & saved 40% on Lead Auditor Training

"Comply Guru’s trainers are not only experienced in their specific fields but are also experts in the art of training. By using a provider who integrates modern self-study e-learning methods with traditional in-person sessions, we can be confident that our learning outcomes are maximized."
Zoran Klaric

Zoran Klaric

Manager Regional Training & Onboarding

Our Methodology

Not all eLearning is the same

Most other providers offer online training that is one-dimensional utilizing either Videos or PowerPoint Presentations. That is not effective training. Our experienced team of subject matter experts, graphical & instructional designers, and training specialists deploy a multi-layered methodology that offers you a New Generation of eLearning.

Not all eLearning is the same
Not all eLearning is the same
 

Course Structure Explained

eLearning Module Breakdown & Timings

An interactive, engaging eLearning experience that you can complete Anytime, Anywhere.

Time Topic
90mins eLearning

Module 1: Introduction to the EU MDR

  • History, Purpose & Structure of the EU MDR
  • Key Terminology
  • Key EU MDR changes
  • EU MDR Timelines for Transition
95mins eLearning

Module 2: Medical Devices covered by the EU MDR

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

Case Study! Medical Device Scope

Case Study! Scope and Legacy Devices
175mins eLearning

Module 3: 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

Case Study! Qualifications of the PRRC

Case Study! Change of Authorized Representative

Case Study! Declaration of  Conformity

Case Study! A PRRC under Pressure
45mins

Certification Exam 1 of 3

  • 30 MCQ-based eAssessment with 70% or higher required to achieve certification
160mins

Module 4: 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

Case Study! Device Classification
160mins

Module 5: 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

Case Study! Route to Conformity
150mins

Module 6: GSPR and Risk Management

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

Case Study! GSPRs 1 – 8
45mins

Certification Exam 2 of 3

  • 30 MCQ-based eAssessment with 70% or higher required to achieve certification
160mins

Module 7: 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

Case Study! Excerpt of a CER for Review
150mins

Module 8: Post Market Surveillance and Vigilance

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

Case Study! Periodic Safety Update Report
145mins

Module 9: Technical Documentation, UDI and EUDAMED

  • Annex II & III: Technical Documentation
  • UDI Requirements & Timelines
  • EUDAMED
  • MDCG Guidance Documents
45mins

Certification Exam 3 of 3

  • 30 MCQ-based eAssessment with 70% or higher required to achieve certification

Our Experts

Meet The People Behind The Course

Our experts possess a wealth of industry experience acquired over years of practical application, and in addition, they demonstrate a combination of unwavering passion and a proven aptitude for training

Michelle Keane

Our Instructor

Michelle Keane

Michelle has a proven track record with over 20 years of experience working across both the Medical Device and Biotechnology sectors. Currently, she is a Lead Auditor for an INAB Accredited Certification Body, and an MDR Assessor for a Notified Body in Europe. In addition, she is the Team PRRC Representative for Ireland.
Leon Donnellan

Our Graphical & Instructional Designer

Leon Donnellan

Leon has over 20 years of experience in eLearning. During his illustrious career, he has spent 10+ years designing programs within highly regulated industries. He brings vast experience to Comply Guru in both graphical and instructional design.
Eoin Philip Kelly

Our Training Specialist

Eoin Philip Kelly

Eoin has almost 20yrs of experience in internationally accredited training design & delivery. He founded Comply Guru to pursue his vision to bridge the major gap in the market for learning solutions that were more accessible, convenient & flexible in a fast-changing world of International Standards & Medical Device Regulations.

Course Overview

EU MDR Training for Practitioners

Key Benefits of Choosing Comply Guru Covered
Globally Recognized Qualification with CQI, IRCA & RAPS
First CQI & IRCA Certified EU MDR Training in the World since 2020
More Flexibility & More Savings vs Other Providers
Industry-leading eLearning Methodology
Up-to-date Technical Content & Examples
Practical Case Studies based on Real-World Scenarios
Course Access for 6 Months
Ask The Instructor
Quick Enrolment within 1hr
Scalable Learning for Teams
Manager Accounts for Groups of 10+
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

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 Certification

CQI IRCA
CQI & IRCA certify this course (No. 2378).

RAPS Approved Provider Logo

The Regulatory Affairs Professionals Society has approved Comply Guru (No. 1007) and recognizes this course where members will be eligible for the stated number of RAPS credits (12).

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)
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.

Watch and Learn More

About Our Training for Practitioners

Learn about how our IRCA Certified MDR Training for Practitioners is leading the industry for innovation through online learning

 
Why Choose eLearning

Customer Reviews

What Our Learners Are Saying

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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.
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.

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Globally Recognized Qualifications
Training credentials that you can trust.
CQI-IRCA Cretified Course
Exemplar Global Cretified Course
RAPS Cretified Course