Classifying Medical Devices in the US and the EU
When : Friday, September 10, 2021
Time : 01 : 00 PM EST
Duration : 60 Minutes
Charles H. Paul is the President of C. H. Paul Consulting, Inc. - a
regulatory, Lean Manufacturing, training, and technical documentation
consulting firm. Charles is a management consultant, instructional
designer, and regulatory consultant and has led C. H. Paul Consulting,
Inc. since its inception over 25 years ago. He regularly consults with
Fortune 500 pharmaceutical, medical device, and biotechnology firms
assisting them in achieving human resource, regulatory, and operational
excellence. He is a regular presenter of webinars and on-site seminars
in a variety of related subjects from documentation development to
establishing compliant preventive maintenance systems. The firm works
globally completing projects throughout the EU, UK, South America, and
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.
- 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
Course Level - Basic/Intermediate
Who Should Attend
Anyone involved in the design, development, marketing, submittal, and approval of medical devices that have had some exposure to the subject area and regulated environments.
- Medical device design engineers
- Medical device research and development associates, scientists, managers, and directors
- Quality assurance and quality control personnel in the medical device industry
- Compliance managers and directors
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 management of your device will be
executed over its lifecycle.