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EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745)

New quality system requirements, classification rules, and conformity assessment procedures – these are just a
few of the hurdles that manufacturers must clear to sell their devices in the European Union (EU) now that the new Medical Device Regulation has been published. 

The new European Union Medical Device Regulation (MDR 2017/745) represents a considerable change from the directives it is replacing. Device manufacturers who conduct business in the EU must start their transition now in order to meet the May 26, 2020 transition deadline. This course is a critical first step. 

During this class you will learn about the new requirements in the 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 transition.

Note: focus of this course is Medical Devices.

Which EU MDR training is right for you?

Do you need to get a foundation in the EU MDR?

Then this is the right class for you.

Do you need to learn how to perform internal or supplier audits to the EU MDR requirements?

Consider our EU MDR Auditor Training

Upcoming Dates and Locations

Please Contact Us if you need additional information or if you don't see a date that works for you. To register by phone, call 1.800.472.6477  |  On-Site training available, learn more »

Location Start Date Days Cost Public Course On-Site
Irvine, CA 07/22/2019 3 $2995.00 Add to Cart CONTACT US
Boston, MA 08/05/2019 3 $2995.00 Add to Cart CONTACT US
Austin, TX 08/12/2019 3 $2995.00 Add to Cart CONTACT US
Minneapolis, MN 08/19/2019 3 $2995.00 Add to Cart CONTACT US
San Francisco Area, CA 09/09/2019 3 $2995.00 Add to Cart CONTACT US
Chicago, IL 09/16/2019 3 $2995.00 Add to Cart CONTACT US
San Diego, CA 09/23/2019 3 $2995.00 Add to Cart CONTACT US
Raleigh, NC 09/30/2019 3 $2995.00 Add to Cart CONTACT US
Orlando, FL 10/07/2019 3 $2995.00 Add to Cart CONTACT US
Edison, NJ 10/14/2019 3 $2995.00 Add to Cart CONTACT US
Minneapolis, MN 10/21/2019 3 $2995.00 Add to Cart CONTACT US
Boston, MA 10/28/2019 3 $2995.00 Add to Cart CONTACT US
San Francisco Area, CA 11/04/2019 3 $2995.00 Add to Cart CONTACT US
San Jose, Costa Rica 11/11/2019 3 $2995.00 Add to Cart CONTACT US
Chicago, IL 11/18/2019 3 $2995.00 Add to Cart CONTACT US
San Diego, CA 12/09/2019 3 $2995.00 Add to Cart CONTACT US

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 existing directives and the MDR.
  • Explain the impact of the new MDR requirements on economic operators, including manufacturers.
  • Describe the different regulatory requirements through life-cycle of device, e.g. premarket, design and development, product realization, and postmarket.
  • Identify the necessary steps to prepare an organization to transition to the MDR.
  • Plan a gap assessment to transition 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 Transition Quality Plan Tool
  • A Pathfinder for the Medical Device Regulation and its Annexes. These serve as tables 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. 

Number of Days: 3
CEUs: 2.5
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Bring any of our classes to your location - Oriel STAT A MATRIX on-site training is the perfect solution for training groups of five or more employees or launching a companywide training effort. It's cost-effective, completely customizable, and absolutely hassle-free. For more information, call 1.800.472.6477 or Contact Us.

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