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GMED North America’s Training Center

European Medical Devices Regulation (EU) 2017/745

Understand and assess the changes introduced by the Regulation
2-day training session | Virtual Classroom


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Next Training Date Aug 20 - 21, 2024 , Training | Virtual Classroom

About the training

The European Union Medical Device Regulation – Regulation (EU) 2017/745 (or EU MDR) – 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 medical device industry companies get ready for their application to obtain and/or maintain CE marking for their product(s) and:

  • Gain an understanding of the changes introduced by EU MDR requirements;
  • 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.



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Florianne Torset Bonfillou

Florianne Torset-Bonfillou Senior International Regulatory Project Manager; Lead Auditor & Product Reviewer, GMED North America

Florianne is a Senior International Regulatory Project Manager at GMED North America. She is also a Lead Auditor and a Product Reviewer with focus on high-risk devices, mainly in the cardio and neurovascular field.

She has a background in Biology, Chemistry and Quality Management. After working in the Pharma/Device industry, Florianne first joint GMED as an Assessor, then became part of the Quality & Regulatory support team. For the past 5 years, Florianne provided Regulatory support to the local team for the transition to the European Regulation EU 2017/745 and EU 2017/746. Since 2023, she supports the UK subsidiary towards its UKCA designation.

She is also a trainer on the European Regulation, Quality Management, Risk Management, and other regulatory and quality topics.

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
  • Group workshop

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
  • Group workshop
  • Summary and Discussion with the trainer
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We serve your passion for progress in the Medical Device Industry

Attendees Testimonials

"The trainer was very knowledgeable and she answered most, if not all questions to the satisfaction of the trainees. The training materials / downloads were very useful as well, and I expect I'll refer to them often."

Sr. Premarket RA Specialist

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