EU Medical Device Classification
Overview:
It is not economically feasible to subject all medical devices to rigorous conformity assessment procedures. A more appropriate graduate system is now available that manufacturers should be able to determine the classification of their product early in the development stage. This medical device classification webinar will review the risk based approach of the EU classification system. This webinar will review two documents on this topic including the "Medical Devices: Guidance Document - Classification of Medical Devices" and "EU Council Directive 93/42/EC (as amended) - Annex IX Classification Criteria" which is applicable on the classification rules for medical devices which intend to ensure a high level of human health and safety.
Why should you attend : Today, medical devices occupy an extensive range of products that vary in intricacy and application. As the global market for medical devices continues to grow, it is important that companies be informed on the rules for classification of medical devices because of potential risk that can be associated with the device can have on the human body when used. This webinar will discuss the application of EU Council Directive on medical device classification.
Areas Covered in the Session
- Basic definitions and purpose of medical device classification
- How to carry out classification by reviewing the application and how to use the classification rules
- Explanation of individual classification rules regarding non- invasive and invasive devises, along with additional rules applicable to active devices and other special rules
Who Will Benefit:
- Quality Managers and Professionals
- Marketing Managers and Professionals
- Risk Managers and Investigators
- R&D Project Managers and Team Members
- Design Engineers
- Consultants