Session 7: Post-market surveillance and vigilance under 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.

Within this e-Learning you will learn what the new requirements for post-market surveillance (PMS) and vigilance are under the IVDR and what the new requirements on trend reporting and post-market performance follow-up (PMPF) include. In the bonus segment you will get more insights into reports required specifically for class C and D IVDs and the required update cycle for the PMS, vigilance and PMPF documents.

 

More topics to be covered in the upcoming sessions

  • Implementation Strategies for IVDR – Timelines and Priorities – Work Packages
  • How REACH affects Medical Devices and IVDs
  • Classification under IVDR
  • Economic operators and regulatory functions under IVDR
  • Performance evaluation and clinical evidence under the IVDR
  • Update of the technical documentation meeting IVDR requirements
  • 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