Day I will deliver the knowledge base for the subsequent days. It will give an overview of the EU device
legislative system and the principles and philosophy behind it. It will explain the definition of a medical
device and the demarcation between medical devices and pharmaceuticals. The course will give a clear guide how to develop practically a medical device. It will show how to
identify the correct development path. Responsibility in post marketing surveillance of medical devices (and drug devices combination
products) according to the Medical Device Vigilance System will be explained and illustrated by
examples.
legislative system and the principles and philosophy behind it. It will explain the definition of a medical
device and the demarcation between medical devices and pharmaceuticals. The course will give a clear guide how to develop practically a medical device. It will show how to
identify the correct development path. Responsibility in post marketing surveillance of medical devices (and drug devices combination
products) according to the Medical Device Vigilance System will be explained and illustrated by
examples.
