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Medical Device Directive (MDD) to Medical Device Regulation (MDR)

The class already has the maximum number of students. For more information or options please call Training Solutions at 800-217-1390.

This course introduces you to the key changes from the European Medical Device Directive (MDD) to the new European Medical Device Regulation (MDR). All medical devices and identified devices without a medical purpose will need to undergo a conformity assessment procedure based on the new MDR requirements, in order to place devices on the European Union market. The course will give a general guideline of how to approach application of the new MDR, and will highlight the differences to the MDD that will affect all manufacturers.

Benefits to Your Business

·         Understand the key changes in the transition from the Medical Devices Directive to the new Medical Devices Regulation

·         Communicate the impact to your organization of the key changes introduced by the MDR, and the transition arrangements defined within the MDR

·         Identify the next steps for your organization to meet the MDR requirement

Learning Objectives

·         On completion of this training, participants will be able to:

·         Explain the changes in the structure and administration of the regulation

·         Recognize new economic operators affected by the regulation

·         Identify key changes to the requirements concerning the following steps for conformity assessment:

·         Check device is within the scope of the MDR

·         Determine risk class of device

·         Select conformity assessment procedure

·         Identify applicable safety and performance requirements

·         Assemble technical documentation

·         Apply conformity assessment procedure    

·         Assign unique device identification (UDI)

·         Complete Declaration of Conformity (DoC)

·         Affix CE mark

·         Post-Market Surveillance and Updates       

·         Explain the main impacts on the QMS relating to the above steps, including:

·         Frequency, extent and conduct of audits

·         Electronic data management and public access to data

·         Clinical investigations, clinical evaluation and post-market surveillance

·         Roles of commercial partners

·         Communicate the transition arrangements as stipulated within the regulation

Intended Audience

Manufacturers of medical devices, especially: Regulatory Affairs, Design and Development, Clinical Affairs Specialists, Quality Management, and Quality Assurance personnel.


Good understanding of the existing Medical Devices Directive (93/42/EEC)

Upcoming Course Dates

The venues for scheduled courses are tentative until receipt of course confirmation from BSI.

Start/End Date and Time Location Fee Enroll
  • Sep 23, 2019 8:00 AM - 4:30 PM
Seattle, WA
Crowne Plaza Seattle Airport
17338 International Boulevard
Seattle, WA 98188
United States
(206) 428-2123map this location
USD $1400.00Enroll
  • Oct 07, 2019 8:00 AM - 4:30 PM
Nashville, TN
Hyatt Place Nashville-Opryland
220 Rudy Circle
Nashville, TN 37214
United States
(615) 872-0422map this location
USD $1400.00Enroll
  • Oct 17, 2019 8:00 AM - 4:30 PM
San José, CA
Biltmore Hotel and Suites
2151 Laurelwood Road
Santa Clara, CA 95054
United States
View Location Websitemap this location
USD $1400.00Enroll
  • Nov 18, 2019 8:00 AM - 4:30 PM
Princeton, NJUSD $1400.00Enroll
  • Jan 21, 2020 8:00 AM - 4:30 PM
San Diego, CAUSD $1400.00Enroll
  • Feb 18, 2020 8:00 AM - 4:30 PM
Nashville, TNUSD $1400.00Enroll
  • Mar 02, 2020 8:00 AM - 4:30 PM
Atlanta, GAUSD $1400.00Enroll
  • Apr 27, 2020 8:00 AM - 4:30 PM
Chicago, ILUSD $1400.00Enroll
  • May 04, 2020 8:00 AM - 4:30 PM
Salt Lake City, UTUSD $1400.00Enroll
  • May 11, 2020 8:00 AM - 4:30 PM
San Diego, CAUSD $1400.00Enroll
  • Jun 29, 2020 8:00 AM - 4:30 PM
Boston, MAUSD $1400.00Enroll