The regulatory pace of change is accelerating for the in-vitro diagnostics (IVD) industry. Evolving regulatory standards impact IVD manufacturers, central laboratories, contract research organizations and manufacturers who bring new IVD devices to the commercial market or sponsor drug or medical device clinical trials that utilize IVD products as part of trial conduct. The In-Vitro Diagnostic Regulation (EU) 2017/746 significantly impacts all IVD manufacturers with approximately 80 percent of all devices in the European Economic Area now requiring some form of conformity assessment by a Notified Body. In Europe, major delays in the start of a device or drug trial can occur in some countries if there is a failure to consider the unique regulatory requirements for IVD devices in medical device or drug protocols.
This interactive course will provide new and intermediate learners with an overview of the United States and EU regulatory requirements for the development, commercialization, and clinical performance studies of in-vitro diagnostic (IVD) devices including the U.S. Code of Federal Regulations, US FDA guidance, ISO 20916, and the In-Vitro Diagnostic Regulation (EU) 2017/746.
Topics include the applicable US Food and Drug Administration and European Union regulations/directives, device classification system, clinical performance study considerations, commercialization routes, and submissions. The interactive course includes lectures, mini-quizzes, and small group case studies/examples to accommodate different learning styles in a safe learning environment.
For more info: https://us-tdm-tso-15eb63ff4c6-1626e-169df4b0a12.force.com/s/lt-event?id=a1Y4U00000J1nPo