Classifying Medical Devices - US and EU

Why Should You Attend:

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

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.

This workshop will provide insight into the classification process as regulated by the FDA and will provide a methodology to assist in properly making your classifications. This workshop will cover the steps for classifying a medical device using the FDA Product Classification Database.

Key definitions related to classifying medical devices will be provided to include intended use, indications for use, risk and general and special controls. Also to be covered, will be the EU medical device classification process compared to the US process.

Learning Objectives:

• List and describe the three US FDA Medical Device Classifications
• Explain how a medical device classification is made
• Explain/define medical device exemptions
• Explain when the medical device exemptions apply
• Explain General and Special Controls
• Explain when General and Special Controls apply
• Explain reclassification
• Define the EU medical device classifications and those classifications are determined

Areas Covered in the Webinar:

• Medical device definitions
• US Medical device classifications
• EU Medical Device Classifications
• Key Terms and definitions
• Explain General and Special Controls and how they are applied
• Types of medical devices
• How US Medical devices are classified
• How EU Medical devices are classified
• List and describe the applicable US and EU regulations for medical device classification

Who Will Benefit:

This webinar is applicable to the Medical Device industry. Titles includes:

• Audit and Compliance Personnel
• Regulatory Professionals
• Quality Professionals
• Risk Managers
• Design Engineers
• Research and Development Engineers
• VP, Directors and Managers of medical device design functions
• Medical device marketing and sales personnel

Instructor Profile: