Are you fit for the new rules in Europe? 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 adapt quickly to the new and more demanding rules on market access in Europe. 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 for staff in research and development, in regulatory affairs and quality management. For all those who are active and responsible in the field of medical technology, biomedical and clinical engineering, e-health and related fields. The new 3rd edition gives the latest stage of regulatory corrigenda, amendments and EU-target dates and reflects the latest Guidance documents of EU on this. Don't be late: those that fail to prepare - prepare to fail!336 pages; 38 Fig., 23 Tab.