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)