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

The EU MDR represents a considerable change from the directives it replaced. These instructor-led classes cover the new requirements in the EU Medical Device Regulation (2017/745), including those related to quality systems, technical documentation, General Safety and Performance Requirements, and postmarket activities. You will also learn how to plan an efficient implementation of the new regulation. This class is for medical device organizations that need a foundation in the EU MDR. If you are an experienced auditor and need to learn how to perform audits to the EU MDR requirements, choose our EU MDR auditor class instead.

Compare Classes

We Offer Two EU MDR Training Classes. Which One is Right for You?

SkillsLab Class ?
DaySmart Class ?

Class Content

In-Depth

Foundational Overview

Class Duration

5 Half-Day Sessions*

6 Hours (One Day)

Teaching Format

Live, Instructor-Led

Live, Instructor-Led

Delivery Options

Virtual or In Person**

Virtual

Certification of Completion

Yes

Yes

Continuing Education Units (CEUs)

2.5

0.6

* SkillsLab classes delivered in-person (private or public) are full-day sessions delivered over 3 consecutive days.

** Interested in private training for your team, virtually or in-person at your facility? See more details or ask us about it!

Upcoming Classes

Upcoming Classes on the EU Medical Device Regulation

SkillsLab $2995

Course Code Location Class Begins Class Ends Daily Schedule Course Delivery Class Agenda Registration
EMF VIRTUAL DELIVERY (Eastern Time) 03 Jun 2024 07 Jun 2024 1:00PM - 5:00PM Eastern US Time Virtual REGISTER
EMF San Francisco Area, CA 09 Sep 2024 11 Sep 2024 8:00AM - 5:00PM Pacific US Time In-Person REGISTER
EMF VIRTUAL DELIVERY (Eastern time - PM) 07 Oct 2024 11 Oct 2024 1:00PM - 5:00PM Eastern US Time Virtual REGISTER

DaySmart $995

Course Code Location Class Begins Class Ends Daily Schedule Course Delivery Class Agenda Registration
EMD VIRTUAL DELIVERY (Eastern Time) 29 May 2024 29 May 2024 10:30AM - 5:30PM Eastern US Time Virtual REGISTER
EMD VIRTUAL DELIVERY (Eastern Time) 27 Aug 2024 27 Aug 2024 10:30AM - 5:30PM Eastern US Time Virtual REGISTER
EMD VIRTUAL DELIVERY (Eastern Time) 01 Oct 2024 01 Oct 2024 10:30AM - 5:30PM Eastern US Time Virtual REGISTER
EMD VIRTUAL DELIVERY (Eastern Time) 17 Dec 2024 17 Dec 2024 10:30AM - 5:30PM Eastern US Time Virtual REGISTER

GROUP DISCOUNT

Save up to

25%

Register 3 people, 4th attends free!

Free

*This offer cannot be combined with any other promotional offer(s).

Course Overview

EU MDR Training: How Deep Do You Need to Go?

Our DaySmart option provides a foundational overview of the MDR. You’ll walk away with a solid understanding of the essentials of compliance. Our SkillsLab class goes deeper into more areas of the regulation, with additional hands-on exercises to apply your knowledge. See the table below and choose the option that fits your needs.

Course Overview
SkillsLab Class
DaySmart Class

Introduction to the EU Medical Device Regulation (EU MDR)

  • Reasons driving the European MDR
  • The transition timeline
  • Major entities and roles in the EU MDR
  • Overview of major requirements in the EU MDR
  • Quality management system linkages

EU MDR Acts

  • EU MDR Implementing Acts and other updates

Quality Management System Requirements

  • Impact of the EU MDR and EN ISO 13485:2016 on the quality management system (QMS)
  • Relationship between ISO 13485 and EN ISO 13485
  • QMS requirements in the EU MDR
  • Roles and responsibilities for QMS implementation and requirements
  • Describe a roadmap for EU MDR compliance and EN ISO 13485:2016 conformance
Workshop! Assessment of EU MDR QMS Requirements

Premarket Activities

  • The risk-based approach to classification for medical devices in the EU MDR
  • Device classification and classification rules
  • Conformity assessment routes
  • Additional requirements for high-risk devices
Workshop! Assess Impact of Premarket Requirements

Technical Documentation

  • EU MDR changes from the existing technical file requirements
  • Technical documentation structure / contents
  • Requirements found in the general safety and performance requirements (Annex I)
  • Technical documentation and postmarket surveillance
Workshop! Examine and Apply Selected GSPR Requirements
Workshop! Assess Technical Documentation Requirements

Common Specifications and Standards

  • Role of common specifications (CS) and harmonized standards
  • Use of life-cycle management strategies to maintain device compliance to the EU MDR

Clinical Evaluation

  • Role of MEDDEV 2.7/1 rev. 4 in EU MDR compliance EU MDR and:
    1. Clinical evaluation
    2. Device equivalence
    3. Clinical evidence
    4. Clinical literature searches
    5. Clinical investigations
    6. Clinical investigation data system
    7. Reporting clinical investigation adverse events
    8. Clinical evaluation report(CER)
    9. Postmarket clinical follow-up (PMCF)
Workshop! Clinical Evaluation Requirements

Unique Device Identification (UDI)

  • UDI traceability requirements in the EU MDR
  • UDI responsibilities and impacts on economic operators
  • UDI electronic system and EUDAMED
  • Global impacts of UDI systems
Exercise! UDI Assignment and Placement

Postmarket Activities

  • EU MDR postmarket requirements in Annex III Part B (technical documentation)
  • EU MDR postmarket surveillance system and reporting requirements including vigilance reporting, trend reporting, serious incidents and field safety action
Workshop! Postmarket Surveillance Requirements

Impact on Auditing

  • EU MDR requirements for Notified Bodies and their impact on manufacturers
  • Describe how Notified Bodies audit under the EU MDR, including assessing the QMS, technical documentation, clinical evaluation, and performing product verification
  • Certification under the EU MDR, including:
    1. Surveillance assessments
    2. Unannounced audits
  • Impact of Notified Body requirements on internal audits
Workshop! Develop a Strategy for Notified Body Audits of Selected Activities

EUDAMED

  • Role of the EUDAMED database in postmarket surveillance

EU MDR Implementation

  • Steps to prepare for implementation of the EU MDR
  • Link internal audit function to EU MDR implementation planning
  • Best practices for EU MDR planning and implementation
Group Activity! Identify responsibilities for planning the EU MDR implementation
What You Will Learn

What You Will Learn

At the conclusion of this training class, you will be able to
SkillsLab
DaySmart

Describe the objectives and structure of the EU MDR. 

Identify the key differences between the requirements found in the previous directives and the EU MDR.   

Explain the impact of the new EU MDR requirements on economic operators, including manufacturers. 

Describe the different regulatory requirements through the life cycle of a device (e.g., premarket, design and development, product realization, and postmarket). 

Identify the necessary steps to prepare an organization to implement the EU MDR.  

Plan a gap assessment to transition an organization to compliance. 

Who Should Attend

Who Should Attend

Intended for medical device professionals working for manufacturers, distributors, importers, and other related parties that market (or plan to market) devices in Europe. Designed for professionals in quality and regulatory affairs, as well as personnel involved in design, risk management, postmarket activities, R&D, and manufacturing. The new regulation expands the organization’s quality management system into new functions impacted by the regulatory requirements, such as production and postmarket activities.

  • RA/QA Specialists
  • Risk Management
  • Postmarket Compliance
  • Engineering and R&D
  • Production Personnel

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