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. It will also explain risk classification of medical devices and the relation between risk classification and conformity assessment procedures. The first day will highlight the role of the notified bodies and the legal basis for the requirements for clinical evaluation and clinical investigation. Also the regulatory route for different types of combination products with pharmaceuticals will be explained. A comparison of the EU and US regulatory systems will conclude day I.


Day II
The course will give a clear guide how to develop practically a medical device. It will show how to identify the correct development path. For medical devices which need to be tested clinically, the process of planning, conducting and reporting a clinical investigation with medical devices will be explained to the course attendees. The practical differences between the development of pharmaceuticals and medical devices will be trained and the challenge of developing a drug device combination product should be sketched.


Day III
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. Differences between risk management of medical devices and pharmaceutical products will be pointed out.
Emphasis that 2007 47 comes into force in 2010.



Event Code:
11539