Classifying medical devices in the us and the EU

Introduction

The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device.

The determination process, how you apply the classification process to your device, is complex and requires several levels of analysis to make the proper device classification.

Proper medical device classification is the fundamental first step in submitting your device for approval anywhere in the world.

This webinar will detail the medical device classification process for the United States through the FDA and will overview the very complex process for medical device classification within the EU. Specifically, this webinar will provide detailed background into the process and will make clear some of the very complex terms and sub-processes associated with medical device classification. We will actually work through the classification process step-by-step for the US and will overview how the process is accomplished for the EU.

Why should you attend?

When designing and developing medical devices it is essential to properly classify your device early on in the process to prevent costly and cumbersome regulatory issues and added or unnecessary work later in the design and development process.

What is the impact? What is the cost? Making the wrong decision – assigning your device a higher classification than necessary within any market, can cost you significant time and money in terms of your submittal process and how the design, development, and the management of your device will be executed over its lifecycle.

Learning Objectives

• Explain the importance of properly classifying medical devices
• Compare and contrast the similarities and differences globally in medical device classification processes
• Explain how to determine if your product is a medical device
• Explain the purpose and function of the medical device classification panels?
• Identify and explain Medical Device exemptions and state when they apply
• Explain the purpose of the product code classification database and explain how is it used?
• Explain the process of classifying medical devices in the EU in terms of the new Medical Device Regulation

Areas covered in the Webinar

• Purpose and reason for classifying medical devices
• Medical device determination
• The medical device classification panels
• Medical Device exemptions and when they apply
• Product code classification database and how it is used
• The process of classifying a medical device in the US
• The process of classifying a medical device in the EU
• The impact of the new EU Medical Device Regulation on EU medical device classifications

Who Will Benefit?

Anyone involved in the design, development, marketing, submittal, and approval of medical devices that has had some exposure to the subject area and regulated environments.

Speaker : Charles H. Paul

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles has been a regulatory consultant for over 20 years and has published numerous white papers on the subject. The firm works with both domestic and international clients designing solutions for complex training and documentation issues.

Time: 01:00 PM EST| 10:00 AM PST | Duration: 60 Minutes