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20hrs Online Course USD $ 1395.00 ★★★★★ 280 Reviews

EU MDR Training 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. It has been specifically designed for Quality & Regulatory Professionals who are new to the Regulation.

Why Comply Guru?

  • CQI, IRCA & Exemplar Global Certified
  • Self-Paced, On-Demand Learning (24/7)
  • Highly Interactive, Engaging Experience
  • Industry-leading Methodology
  • Designed by Experts with Proven Expertise
EU MDR 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 training, successful Learners will have the knowledge needed to:

  1. Explain the history, purpose, and structure of the EU MDR, and the key terminology used throughout the regulation
  2. Identify the types of devices covered by the EU MDR and the rules for classifying these devices
  3. Describe the obligations of the economic operators and the PRRC
  4. Describe the General Safety & Performance Requirements and the key features of a risk management system based on ISO 14971
  5. Describe the contents of the Technical Documentation and the requirements for Post Market Surveillance, Vigilance, and Clinical Data
  6. Explain the Unique Device Identifier requirements and the relationship with EUDAMED

Module Content

A summary of learning topics within this course include:

  • History, Purpose & Structure of the EU MDR
  • Key Terminology
  • Key EU MDR changes
  • EU MDR Timelines for Transition
  • What is a device?
  • Devices in & out of scope
  • Non-Medical devices
  • Overview of Chapter II
  • Articles 5-9
  • Economic Operator & PRRC Responsibilities
  • Articles 16-24
  • Overview of Annex VIII
  • Class Types & Classification Rules
  • Overview of Conformity Annexes
  • Annexes IX, X & XI
  • Custom Made Devices
  • Notified Body Articles & Annexes
  • Overview of Annex I
  • Chapter I General Requirements
  • Risk Management (ISO 14971)
  • Chapter II Design & Manufacture
  • Chapter III Device Information
  • Overview of the Clinical Evaluation requirements including Article 61-62 and Annex XIV
  • Overview of PMS Articles 83-86
  • Overview of Vigilance Articles 87-89
  • Annex II and Annex III Technical documentation
  • Unique Device Identification (Annex VI)
  • UDI Timelines
  • Overview of 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

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

Assessment Methodology

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

Course Accreditation

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.

Exemplar Global

Exemplar Global also certify this course under the Recognized Training Provider scheme. Learners will receive dual accreditation where both logos will appear on their 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 MDR 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
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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