Session 4: Roles and Responsibilities of Economic Operators 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 the impact of the IVDR on economic operators such as manufacturers, importers and distributors. It helps you understand how obligations were shifted and provides answers to the most commonly asked questions (e.g. how to handle and overcome the OEM/PLM relationship under the IVDR).

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
  • 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, Management
Language: 
English
Requirements: 
Basic knowledge in the field of IVDs