Session 5: Performance evaluation and clinical evidence under the IVDR

Don’t miss our e-learning on IVDR implementation strategies.

In a series of 9 sessions we will help you to understand how the new IVDR will affect your product.

This e-learning session is focused on how to analyse data to establish and/or verify the scientific validity, the analytical performance and the clinical performance of your IVD device in order to prepare a proper performance evaluation under the IVDR. It will also answer key questions such as: “Do I need additional clinical studies?” or “Can I use data from equivalent or legacy products?”.

 

More topics to be covered in the upcoming and previous sessions

  • Implementation Strategies for IVDR – Timelines and Priorities – Work Packages
  • When Medical Devices and IVDs meet REACH
  • Classification under IVDR
  • Economic operators and regulatory functions under IVDR
  • Update of the technical documentation meeting IVDR requirements
  • Post market surveillance and vigilance under the IVDR
  • EUDAMED and UDI under IVDR

 

After confirmation of your registration by knoell Germany GmbH, you will receive a link and an access code. From the time you receive the access code, the link to the e-learning video is valid for 56 days. The video can only be accessed five times during this period.

Details
Target audience: 
Regulatory Affairs Manager, Clinical Affairs, Quality Management, Transition Manager, Management
Language: 
English
Requirements: 
Basic knowledge in the field of IVDs