Substance-based Device Regulation

This training currently has no open sessions. If you would like to attend, please leave us a message, and we will inform you when a new date is planned.

Training Objectives:

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

Training Content:

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

• Regulatory pathway of substance-based products 
• Qualification of a substance-based product 
• Risk classification of substance-based medical devices  
• Additional requirements 
• Examples
• Exercise 

Training Format:

• Presentation with interactive discussions
• Exercises during the training
• End of training assessment (participants will receive a training certificate)