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Introduction to the Medical Device Regulation (EU) 2017/45

This course covers the European Regulation for Medical Devices. By the end of this course participants will have a strong foundational knowledge of the EU MDR.

Course Details

The aims and learning outcomes of this course are:

  • To understand the European Regulation for Medical Devices.
  • To appreciate the EU requirements for selling Medical Devices.

Following completion of this course, participants should:

  • Understand the European Medical Device Regulation.
  • Be able to actively participate in preparing documentation for technical files.
  • All participants should have a 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 Medical Device Regulation and is broken down into 5 modules.

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