You will understand how the new European IVDR was developed and when it will be fully applicable. Where you can find why this new regulation was developed; what the content is of its 10 chapters and how it needs to be applied per the 15 annexes. You will understand the major changes of this new regulation which is centered around clinical evidence. The new classification and its conformity assessment are explained. New processes, new terms and acronyms are shown. The many post-market changes are discussed. The roles and responsibilities of the economic operators are presented, including the person responsible for regulatory compliance. In house assays and distance sales are mentioned. Finally a timeline of the implementation is shown. A lessons learned concludes this e-learning course.