EU Medical Device and IVD Regulation Training

  • Overview
  • Learning Outcomes
  • Course Agenda
  • Who Should Attend?
  • Trainer Profile

The European regulatory landscape is set to change, becoming stricter and more technically challenging for medical device companies. With major changes to device classification and requirements for technical documentation, companies will need to plan carefully to ensure they understand the requirements and have the appropriate resources in place. This one- or two-day course examines the new regulations, the likely impact on medical device companies and the steps you can take to navigate the new regulatory environment.

Learning Outcomes

Upon completion of this course, you will be able to interpret and plan for the EU regulatory changes with particular focus on their impact both operationally and strategically.

Course Agenda

  • Overview of the changes
  • The top five things affecting high- and low-risk medical devices and in vitro diagnostic devices (IVDs)
  • Strategic elements:
    • Process changes
    • Product to market assumptions
    • Personnel requirements
    • EU medical device shareholders and decision makers – new structures
  • Business elements:
    • Submission process to notified bodies – Classification and conformity assessment
    • Technical documentation
    • Top five actions and project plans – High-risk devices, IVDs
    • Budgets and resources

Who Should Attend?

This class is useful for all management and executive personnel with responsibility for medical device regulatory lifecycles, involvement with the design and implementation of quality management systems or involvement with product design and development.

Trainer Profile

NSF's courses are taught by experts who have years of experience in medical device quality standards and regulatory requirements. Our trainers are committed to creating a learning environment that is highly interactive and based on real scenarios to help you apply practices and improve behaviors within your workplace. Learn more about our trainer for this course:

Upcoming Courses & Webinars

In EU Medical Device and IVD Regulation Training
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  • “The day was excellent. The technical content and relevance were very good.”Simon Redfern / Smiths Medical
  • “This course has perfectly provided the learning needed for current projects at work.”Wolfgang Angermann / Stryker, Ireland
  • “Great course; challenging with nowhere to hide in the background and plenty of chances to ask general questions.”Peter Iddon / Neotherix