Session 2: When Medical Devices and IVDs meet REACH

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 how the REACH regulation on chemicals impacts your IVDs. The session will provide you an idea on how to monitor critical product components and what to do when your IVD contains substances of concern or substances where a sunset date is defined.

 

More topics to be covered in the upcoming and previous sessions

  • Implementation Strategies for IVDR – Timelines and Priorities – Work Packages
  • 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
  • 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: 
Research and Development, Engineering, Raw Material Purchasing, Regulatory Affairs Manager, Quality Management
Language: 
English
Requirements: 
Basic knowledge in the field of IVDs