When you as a manufacturer have qualified your medical device according to the regulations for medical device products (Medical Device Regulation (MDR) or for in-vitro diagnostics (In-Vitro Diagnostic Regulations, IVDR), you will need to classify your product. Both regulations have a risk-based classification and your product class governs many of the choices in your process for CE marking.

Course description:

During this webinar, we take a brief look at the regulations (MDR & IVDR) and their definitions. You will receive an initial overview of the concept of risk and then look in a little more detail at the regulations’ different classification rules. You will receive an insight into, and see examples of, different types of products, as well as gain knowledge of different decision trees.