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Implementing the EU’s New Medical Device Regulation (MDR 2017/745)

Can't travel? This class is also available virtually.

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, 2021 transition deadline. This course is a critical first step. 

During this instructor-led class (online or classroom format 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.

Note: focus of this course is Medical Devices. For IVDs, see our IVDR Implementation Class

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

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 Course Private
VIRTUAL DELIVERY (PM) 10/12/2020 5 $2995.00 Add to Cart CONTACT US
VIRTUAL DELIVERY (PM) 11/16/2020 5 $2995.00 Add to Cart CONTACT US
VIRTUAL DELIVERY (PM) 12/14/2020 5 $2995.00 Add to Cart CONTACT US
VIRTUAL DELIVERY 01/11/2021 5 $2995.00 Add to Cart CONTACT US
VIRTUAL DELIVERY 02/15/2021 5 $2995.00 Add to Cart CONTACT US
VIRTUAL DELIVERY 03/22/2021 5 $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. 

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.
In-Person Days: 3
CEUs: 2.5

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:

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

VIRTUAL CLASS TIMES Close

Public virtual seminars run daily from 1:30-5:00 p.m. EST (3.5 hours each day).

Auditor classes that require a final exam are extended by 2 hours on the last day to administer the final exam.

For more information download the virtual course agenda (close this window and navigate to the top of the course page) or Contact Us.

Get answers right now. Call 1.800.472.6477

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