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Introduction to the In Vitro Medical Device Regulation (EU) 2017/746

This course covers the In Vitro Medical Devices Regulation. By the end of this course, participants will have a strong foundational knowledge of the EU IVDR regulations.

Course Details

The aims and learning outcomes of this course are:

  • To understand the In Vitro Medical Devices Regulation.
  • To appreciate the EU IVDR requirements In Vitro Medical Devices.

Following completion of this course, participants should:

  • Understand the EU Medical Device Regulation.
  • Be able to actively participate in preparing technical file documentation.
  • Have a good working knowledge of the requirements.

This is a one-day course in which participants will fully engage with the lecturer through group and individual exercises.  There are plenty of opportunities to ask questions, and the course can be fully tailored to the company’s products and internal structure. 

This course explores the European In Vitro Medical Device Regulation and is presented in 5 modules.

  1. Introduction.
  2. Classification & Conformity.
  3. GSPRs & Risk.
  4. Clinical Evaluation.
  5. Post-Market Activities.