COURSE OVERVIEW

In Vitro Diagnostic Regulation 2017/746

The IVDR will replace the current EU Directive on in Vitro Diagnostic Medical Devices (98/79/EC) and will be effective in all EU member and EFTA states. This means that there are significant changes in requirements compared to the previous IVD Directive. Through this training, you'll gain clarity on exactly what has changed, as well as practical guidance for updating your quality system, economic operator oversight, labelling and technical documentation.

Our industry-leading experts have created this course to give you an appreciation for the changes and new requirements of the IVDR and provide practical skills and guidance on how to transition to the new regulation.

Course Information

Course Syllabus 

Course Agenda

This course will explore the following topics:
  • Reasons for the IVDR
  • Structure and key changes of the IVDR
  • Key terminology and definitions
  • Introduction to CE Marking
  • Placing a device on the market
  • Manufacturer’s articles & obligations
  • Economic Operator & PRRC Responsibilities
  • Declaration of conformity
  • Overview and structure of the classifications
  • Annex VI - Class Types & Classification Rules
  • The General Safety and Performance Requirements
  • Routes to conformity

Learning Objectives

  • Understand the purpose and structure of the IVDR
  • Identify the types of devices covered by the IVDR and the rules for classifying these devices
  • Understand the requirements for manufactures and economic operators
  • Gain a solid understanding of the safety and performance requirements
  • Understand post-market surveillance and the associated reports
  • Explain the UDI requirements and the relationship with Eudamed

Who Should Attend? 

This training course is recommended for anyone making and selling devices into the EU:

  • Regulatory Affairs Professionals
  • Research and Design Engineers
  • Quality Managers
  • Quality Engineers
  • Authorised Representatives
  • Consultants

Don't just take our word for it

Witness it first hand, directly from our previous attendees 
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"Thanks a million, the course was excellent and very enjoyable!"

Carolyn B

GS Medical
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