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European Medical Devices Regulation (EU) 2017/745

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Next Training Date Jul 13 - 14, 2023 , Training | Virtual Classroom

About the training

The European Regulations on Medical Devices (including Active Implantable Medical Devices AIMD) – MDR EU 2017/745 – was published on May 5th, 2017 and entered into force on May 25th, 2017. GMED North America has designed a comprehensive training course to help companies get ready for their application to obtain and/or maintain CE marking for their medical device product(s) and:

  • Gain an understanding of the changes introduced by both European Medical Device Regulation – MDR EU 2017/745;
  • Assess the impacts of those changes on their organizational and structural activities.


Good knowledge and effective practice of the Directives 93/42/EEC or/and 90/385/EEC.     

             ⇒ VIRTUAL TRAINING BUNDLE:                                 

Save up to $350 by combining this training with “Technical Documentation per (EU) Medical Devices Regulation 2017/745” training (This offer is only available for the July & August sessions).



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Florianne Torset BonfillouFlorianne Torset-Bonfillou  Regulatory Affairs and Education Leader, GMED North America

Sept. 27-28 session



IbimIbim Tariah                        Senior Advisor Regulatory Strategy and Product Reviewer, GMED North America

July 13-14 session                                                         Dec. 7-8 session

Who Should Attend

  • Medical Device Manufacturers: Senior Management , Regulatory Affairs Managers and Quality Managers, R&D specialists, Development, Manufacturing and Marketing Managers
  • Internal and external Auditors
  • Importers
  • Distributors

Learning Objectives

  • Address the new Quality Management System (QMS) requirements
  • Understand the Product Classification criteria’s and Conformity Assessment routes and how it applies to their device(s)
  • Assess the impacts on the Technical Documentation for Medical Devices in relation with Product Classification criteria’s
  • Identify the expectations with respect to the Clinical Evaluation, Clinical Data(s) and Risk Management
  • Implement the requirements for labelling, the Unique Device Identification (UDI) and EUDAMED
  • Address the expectations with respect to the requirements pertaining to the Post market Surveillance and Vigilance reporting (Periodic reports etc.)

Educational Resources

  • Presentations
  • Practical working sessions
  • Course evaluation

Check out the Program

Day 1 & 2
  • Regulation structure
  • Scope and Definitions
  • Actors and Responsibilities
  • Device Classification Criteria
  • Conformity Assessment routes
  • Quality Management System requirements
  • Technical Documentation
  • Post Market Surveillance and Vigilance reporting requirements
  • The Transition
  • Practical working sessions
  • Group workshop
  • Course Evaluation
  • Summary and Discussion with the trainer
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We serve your passion for progress in the Medical Device Industry


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Attendees Testimonials

“Great and relevant situational examples of what the trainer has seen based on her experience as it relates to the subject content. Overall, I am very happy I went to the workshop. I feel better equipped to tackle the MDRs.”

Lisa Maloney Director of Regulatory Affairs and Quality Assurance

“The trainer was very knowledgeable and open to my many questions. Workshop activities were helpful. I feel more confidence in leading our organization toward the new MDR world.”

Martha Rumford Director, QA/RA

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