Session 3: Classification under IVDR – Challenges and Opportunities

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 IVDR e-Learning session is focussed on potential re-classifications of your IVDs and the respective impact on your conformity assessment procedures. Based on practical examples, we walk you through the actions and steps to be taken when your products need to be up-classified.

 

More topics to be covered in the upcoming and previous sessions

  • Implementation Strategies for IVDR – Timelines and Priorities – Work Packages
  • How REACH affects Medical Devices and IVDs
  • Economic operators and regulatory functions under IVDR
  • Performance evaluation and clinical evidence under the 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, Quality Management, Transition Manager
Language: 
English
Requirements: 
Basic knowledge in the field of IVDs