EU MDR 101: Introduction, Overview, and Implementation Process of the EU MDR (2017/745)

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About Course

EU Medical Device Regulation (MDR) 2017/745

EU MDR 101 Online Training Course

COURSE DESCRIPTION

This course aims to provide learners with the knowledge, clarity, and confidence to implement the new EU MDR (2017/745) regulation, using leading teaching methods designed to increase knowledge retention and skill application.

COURSE OBJECTIVES

  • Provide a detailed review of the EU MDR Regulation legal framework, structure, scope, and content.
  • Present the information structured in a way that will serve as a roadmap for the implementation process.
  • Outline a different perspective of what the EU MDR Regulation represents, to highlight its benefits.

COURSE CERTIFICATION

🎓

Certificate of Completion

Issued by EU MDR Certified Trainer

Course graduates will:

  • Gain detailed understanding of EU MDR Regulation legal framework, structure, scope, and content
  • Receive structured roadmap for successful implementation process
  • Develop unique perspective on EU MDR benefits and strategic advantages

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DOWNLOAD THE EU MDR TRAINER QUALIFICATIONS PACKAGE HERE

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Course Content

Lesson 1
This section sets the foundation for the course. In Welcome and Introduction, learners are greeted and given an overview of what to expect. In Course Objectives, the key goals and learning outcomes are outlined, helping learners understand the purpose of the course and what they will achieve by the end.

  • Welcome and Introduction
    03:57
  • Course Objectives
    00:48
  • Course Content and Structure
    05:24
  • Course Materials and Format
    00:34
  • Instructor Qualifications

Lesson 2
Under this section, we will start by reviewing the regulation’s date of application and transitional provisions so we can understand the deadlines by which we need to implement this regulation into our quality management system and into our technical documentation.We will also review the details and limitation of the transitional provisions given by the regulation. We will review the structure of the legislation under EU law so we understand how to read and interpret the regulation. We will review the reasons why the European Commission decided to release this regulation and by doing so, we will understand how the implementation of this regulation represents a benefit to our industry. Finally, we will explore the tools under the EU law that can be used to amend, change, or modify the regulation so we understand how any of these may impact the content of the regulation.

Lesson 3
At this stage, we will review the scope of the regulation to understand if the devices we are planning on offering into the EU market are covered by the regulation. In other words we will explore how to determine if our product or service falls under the scope of the regulation.

Lesson 4
Under this section, we will review compliance requirements from a quality management system perspective. What articles we need to reference to ensure that our QMS is able to demonstrate conformity to the regulation.The review of the level of conformity of our QMS is something we need to perform at least 3 times: once under an initial gap determination, once through the remediation process, and at least once to obtain a final verification of compliance and conformity. This is usually performed under an internal audit process.

Lesson 5
After we determine that our products and/or services are under the scope of the regulation, the next step would be to determine the risk classification of the product. Once we know what is the classification of our product, we can then determine a path to market; or as referenced by the regulation, a conformity assessment.

Lesson 6
Under this section we will explore the parameters we would take into consideration to select a conformity assessment. We will therefore review the related annexes we need to consider in this selection process.

Lesson 7
We will review the content of Annex I with title General Safety and Performance Requirements of the EU MDR to understand how it is divided and some important provisions under it.

Lesson 8
This lesson will review the requirements of the technical documentation in accordance with the regulation, noting that having a conforming technical documentation is a requirement of all product classes under the MDR and for devices listed under Annex 16.

Lesson 9
Once we have our QMS conformity verified and we have our updated technical documentation, we will then apply our selected conformity assessment process. This means that we will then request a notified body, as applicable, to perform the required assessment so we can then obtain our related certificates. Under this section we will review the considerations we need to have to select a notified body. We will also review the process of obtaining and maintaining these certificates. Finally, we will review the additional requirements we need to implement into our QMS and our products to be able to plan for the release of our product to market.

Lesson 10
This lesson shows us how we will finalize our conformity assessment process and implement the final steps prior to the release of our products into market.

Lesson 11
We will review in more detail provisions related to PMS requirements and processes, and we will also review information related to what constitutes a significant change under the MDR that may trigger a premature mandatory transition into the MDR.

EU MDR 101 Course Exam
1. Examination Philosophy and Details This is an open book, open-note examination. The goal is to assess your ability to locate, interpret, and apply the EU MDR requirements using official sources, just as you would in your professional role. Success depends on your familiarity with the course materials and your skill in finding the correct information.- Exam title: EU MDR 101 Open-Book Certification Examination - Content coverage: Entire course curriculum - Question format: Multiple choice questions (MCQs) - Total number of questions: 30 - Passing score: 80% (You must correctly answer at least 24 questions)2. Authorized Resources You are encouraged to use the following materials to answer the questions:- All provided course slides and notes. - The official consolidated version of regulation (EU) 2017/745. - The text of all amending regulations discussed in the course (e.g., 2023/607, 2024/1860, 2024/568. - Any MDCG guidance documents referenced in the course materials. - Your own personal notes made during the course.