Tutorial 04: Introduction to Medical Device Regulation

This tutorial will give a condensed overview of the EU device legislative system and the principles and philosophy behind it. It will explain the definition of a medical device and subsequently the delineation between medical devices and pharmaceuticals. Also the characteristics and the organisational structure of the medical device sector and the role of the various stakeholders in it will be highlighted. It will explain the concept of risk classification of medical devices and the relationship between risk classification and conformity assessment procedures. It will highlight the role of the Notified Bodies in the system and the main provisions on clinical evaluation and clinical investigation. It will discuss the headlines of the EU regulation of In Vitro Diagnostics, with a focus on the differences with the medical device regulation. The theoretical concepts will be illustrated with practical examples.

Professionals in the pharmaceutical area (e.g. regulatory affairs, clinical development), who either are involved in the development and marketing of drug device combinations or who would like to obtain a condensed overview of the EU Medical Device regulatory system.

This tutorial provides a knowledge base for Theme 7, Devices & in Vitro Diagnostics and Combination Products

At the conclusion of this tutorial, attendees will be able to:

• Understand the main characteristics of the EU Medical Device regulatory system, including the provisions on risk classification, conformity assessment, Notified Bodies, clinical evaluation and clinical investigation
• Understand the delineation between pharmaceutical and medical devices