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GMED North America’s Training Center

European in Vitro Diagnostic Device Regulation (EU) 2017/746

Understand and assess the changes introduced by the European Regulation 

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2 days of training | Virtual Classroom | $1600 pp

 

 

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Next Training Date Feb 09 - 10, 2027 , Training | Virtual Classroom

About the training

  • The European Union Medical In Vitro Diagnostic Device Regulation – Regulation (EU) 2017/746 (or EU IVDR) – entered into force on May 26th, 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 in vitro diagnostic device product(s) and: 
    • Gain an understanding of the changes introduced by EU IVDR requirements; 
    • Assess the impacts of those changes on their organizational and structural activities. 

REQUIRED LEVEL

Good knowledge and effective practice of the Directives 98/79/EC.

         

 

Trainers

Tom PattenTom Patten

IVD International Manager, GMED

 

Tom Patten is the IVD International Manager at GMED, with broad experience across the in-vitro diagnostics sector. His background includes laboratory work, product development, and R&D for molecular oncology devices, as well as seven years of notified body experience. Tom contributed to the successful designation of an IVD notified body under the IVDR (EU) 2017/746. In his current role, he supports manufacturers with global IVDR/IVD regulatory strategy, structured dialogue sessions, and international market access, bringing practical industry and notified body perspectives to his training sessions.

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

  • Identify the major changes between the Directive and Regulation
  • Understand the structure of the Regulation
  • Understand the new requirements of the Regulation

Educational Resources

  • Presentations
  • Practical working sessions
  • Course evaluation

Check out the Program

Day 1 & 2
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Program
  • Regulation structure
  • Scope and Definitions
  • Actors and Responsibilities
  • Device Classification Criteria
  • General safety and performance requirements
  • Conformity Assessment routes
  • UDI
  • Performance evaluation
  • Method of proof
  • Specific procedure
  • Post Market Surveillance
  • Requirements for the Vigilance system
  • Eudamed
  • Transitional arrangements
  • Summary and Discussion with the trainer
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Attendees Testimonials

The trainer is very knowledgeable and was able to make comparison with the IVD 98/79/CE and the FDA regulations. The training pace was good. The presentation of the 2017/746 regulation was very clear and gives an accurate overall of it.
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Sr. Regulatory Affairs Specialist

All-important requirements of the IVDR are well explained and some examples are given to better understand.
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Regulatory Affairs Specialist

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