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EU MDR 2017/745 Implementation Training Course

As of May 26, 2021, device manufacturers who conduct business in the EU and do not have a valid MDD certificate must now follow the new EU Medical Device Regulation (MDR 2017/745)

The new EU MDR represents a considerable change from the directives it replaced. During this instructor-led class (online or classroom formats available) you will learn about the new requirements in the EU Medical Device Regulation (MDR), including those related to quality systems, product classification rules, technical documentation, clinical evaluations, Unique Device Identification (UDI), and postmarket surveillance. You will also learn how to plan an efficient implementation of the new regulation.

This class is for medical device organizations who 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 Training class instead.

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Course Date

Upcoming Dates and Locations

Virtual seminars run as 1/2-day sessions. In-person classes run as full-day sessions. See the virtual session daily class times.
Location Start Date Days Cost Public Private
VIRTUAL DELIVERY (Eastern Time) 02/06/2023 5 $3295.00 Add to Cart Contact Us
Boston, MA 03/06/2023 3 $3295.00 Add to Cart Contact Us
VIRTUAL DELIVERY (Eastern Time) 03/20/2023 5 $3295.00 Add to Cart Contact Us
Orlando, FL 05/01/2023 3 $3295.00 Add to Cart Contact Us
VIRTUAL DELIVERY (Eastern Time) 05/22/2023 5 $3295.00 Add to Cart Contact Us
VIRTUAL DELIVERY (Eastern Time) 07/17/2023 5 $3295.00 Add to Cart Contact Us
VIRTUAL DELIVERY (Eastern Time) 09/18/2023 5 $3295.00 Add to Cart Contact Us
San Francisco Area, CA 09/25/2023 3 $3295.00 Add to Cart Contact Us
Chicago, IL 11/06/2023 3 $3295.00 Add to Cart Contact Us
VIRTUAL DELIVERY (Eastern Time) 11/13/2023 5 $3295.00 Add to Cart Contact Us
VIRTUAL DELIVERY (Eastern Time) 12/04/2023 5 $3295.00 Add to Cart Contact Us

Course Detail

Course Objectives

At the end of this workshop, participants will be able to:

  • Describe the objectives and structure of the MDR.
  • Identify the key differences between the requirements found in the former directives and the MDR.
  • Explain the impact of the 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 follow the MDR.
  • Plan a gap assessment to guide an organization to compliance.

Course Topics

  • The objectives of the MDR, including the significance of replacing directives with a regulation
  • Quality management system requirements in the MDR
  • Device classification and conformity assessment route changes in the MDR
  • Technical documentation requirements in the MDR
  • Clinical evaluation process requirements in the MDR
  • UDI and traceability requirements in the MDR
  • Postmarket surveillance and reporting requirements in the MDR
  • Life-cycle review of products linked to risk management and clinical evidence
  • Auditing impact of the MDR

Highlighted Handouts and Resources

  • Matrix of Annex I Requirements (MDD Essential Requirements Compared to MDR General Safety and Performance Requirements)
  • MDR Implementation Quality Plan Tool
  • A Pathfinder for the Medical Device Regulation and its Annexes, which serves as a table of contents for the 175+ page regulation
  • EU Glossary with definitions of key terms

Who Should Attend

Medical device professionals in areas of quality and regulatory affairs, design, risk management, postmarket activities, R&D, and manufacturing, who work for manufacturers that market devices in the EU. 

Virtual Class Days

  • This training is delivered as five consecutive half-day sessions.
  • Daily sessions run from 1:00-5:00 p.m. Eastern Standard Time.
  • Virtual Half-Days

    5
  • In-Person Full-Days

    3
  • CEUs

    2.5

Virtual Session Details

Virtual Session Details

Oriel STAT A MATRIX Virtual Instructor-Led Training (VILT) is a real-time internet-based learning experience where the instructor and learners are in separate locations. Oriel STAT A MATRIX’s VILT technology platform is designed to simulate a traditional in-person classroom experience and allows for 2-way dialogue, break-out sessions for engaged workshops and hands-on exercises, and group work using virtual breakout rooms. This provides for an engaging learning experience in which participants can connect with the content and interact with both the instructor and other classmates.

Online Training Schedule

  • This training is delivered as five consecutive half-day sessions.
  • Daily sessions run from 1:00-5:00 p.m. Eastern Standard Time.
  • This convenient half-day format allows you to balance your other responsibilities while still getting the training you need. 

Technical /Logistical Requirements

To participate in this learning, first and foremost, we need your engagement!  You will also need:

  • PC MAC Computer

    PC or MAC Computer

  • Reliable Internet

    Reliable Internet

  • Video Webcam

    Video Webcam

  • Headset or Earbuds

    Headset or Earbuds

  • Quiet Setting

    Quiet Setting

  • Two Monitors Recommended

    Two Monitors

See course dates to find / register for a virtual online session of this course.

Virtual Session Details

Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

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