Session 8: EUDAMED and UDI 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 get an overview on the main objectives, the underlying regulations, important stakeholders and the overall structure of EUDAMED (European Database on Medical Devices) and the UDI (Unique Device Identification) system as defined in the Regulation (EU) 2017/746 on in vitro diagnostic medical devices.

 

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
  • 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
  • Post market surveillance and vigilance under the 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