The process for CE marking according to MDR and IVDR

Course description:

This webinar provides you with a comprehensive introduction to the CE marking process according to the Medical Devices Regulation (MDR) and the In-Vitro Diagnostic Regulations (IVDR). Products affected must be CE marked in order to be marketed within the EU.

The product first needs to be qualified as a medical device and then classified, all based on the intended purpose. Then the strategy and path for CE marking can be developed.

After the webinar, you will have knowledge of the different paths a manufacturer can take to CE mark a product.

You will be familiar with the definitions of a medical device and understand how to qualify your product as a medical device. You will be familiar with the concept of intended purpose.