This webinar will provide an overview of the current state and upcoming updates of the IVD regulatory requirements, including a brief introduction and transition timeline of the 2017/746 EU IVDR as well as the US FDA’s revised approach to regulating Laboratory Developed Tests, etc.

Agenda

• EU IVDR basic concepts (scope, definitions, classification rules, conformity assessment routes)
• EU Reference Laboratories (EURLs)
• EU IVDD - IVDR implementation and transition timelines and strategies
• US FDA Laboratory Developed Test rules
• Software as IVD device

Target Audience: The webinar will be useful for anyone interested in learning more about regulatory requirements of IVD devices, primarily regulatory and quality professionals of IVD manufacturers.

Language: English
Cost: No Charge

Can't make a live session? Register now and receive a complimentary recording after the live event. For further information, please contact: KN.NAM.Marketing@sgs.com