The new EU regulations on medical devices and in vitro diagnostic medical devices (IVDs) are changing the rules of the game in this important area of health care. It is now necessary to make use of the transitional periods and adapt quickly to the new and more demanding rules on market access. This requires a thorough knowledge of the new rules for all those responsible and employed in the sector. A sound knowledge of the new EU regulations is also indispensable for the education, training and further education of students, and staff in research and development, regulatory affairs and quality management, active in the field of medical technology, biomedical and clinical engineering, e-health and related fields. 240 pages; 35 Fig., 18 Tab.

Dr. Wolfgang Ecker has played an active role in shaping the new EU regulations in the EU Council. He conveys the necessary know-how first-hand. As head of department in the Austrian Ministry of Health for many years, he was also a member in important committees and working groups of the EU for medical devices and IVDs and in GHTF. He holds lectures at universities of applied sciences for medical technology and biomedical engineering and lectures for health and medical technology clusters as well as for players in business and healthcare.