Fundamentals of EU IVDR Regulations for In-Vitro Medical Devices

Legislations made across the European Union are taken seriously, especially if they are related to the health of humans. EU IVDR (In-vitro Diagnostic Device Regulation) has been implemented across the European Union, and medical device manufacturers, importers, and distributors should comply with each. Knowing that IVDR has replaced IVDD (in-vitro Diagnostic Directive) is crucial. Compared to the directive, the regRegulationntains a lot of new requirements, annexes, and conditions.

Course developers at Exoexcllence Consultants developed this short course. They have used their expertise to present to learners, especially those interested in regulatory and compliance matters. When such students enroll in this course, they will learn the essentials of this directive, such as how it classifies the in-vitro diagnostic devices, the rules of classifying the devices, and the risk management principles of the regulation the course also looks at the labeling requirements of EU IVDR.

The course comprises a single module divided into four essential topics. Its content includes a video, graphical illustration, and tabs, all presented in simple and comprehensible language. The course also contains two resources that will help students learn profoundly about the regulations' essentials. By completing this course, students will learn enough to support the manufacturers and other stakeholders who want to manufacture, import, and distribute in-vitro devices in the European Union.