This course will give clear and practical guidelines on how to navigate the development of a medical device in the regulatory landscape, and how to identify the correct development path. It focuses on Europe, but also addresses global standards.
Overview of the EU device legislative system and the principles and philosophy behind it will be discussed. Instructors will also explain the essential features of EU medical device regulation, such as essential requirements, risk classification, the relationship between risk classification and conformity assessment procedures and the role of notified bodies.
For medical devices that need to be tested clinically, the process of planning, conducting and reporting a clinical investigation with medical devices will be described in detail.
Furthermore, the process of drafting a design dossier will be highlighted, both for medical devices and for combination products.