Speaker: Dr Cornelia List

Training Objectives 

The goal of this training is to provide participants with an introduction of substance-based devices and its associated challenges under the EU Medical Devices Regulation (Regulation (EU) 2017/745). The training is aimed at anyone who seek to enhance their knowledge and competences within this field.

Training Content

By attending this training, you will receive an introduction on what is a substance-based product and how it qualified as such. After a general introduction of substance-based devices and its requirements to be considered for a regulatory pathway the focus will lie on substance-based medical devices falling under rule 21.

  • Regular regulatory pathway of substance-based products
  • Qualification of a substance-based product
  • Risk classification (in case of a substance-based medical device)
  • Additional requirements
  • Examples
  • Exercise

Training Format

  • Presentations with interactive discussions
  • End of training assessment


EUR 415 incl. course material and certificate


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