Medical devices are widely used – from prevention and diagnostics to treatment and rehabilitation. They are indispensable for the health sector, and do represent an important economic factor. Efficacy and safety of a product is of key importance for patients and users.

CE-marking has to be affixed on all medical devices in Europe and is the visible feature of conformity of the medical device with essential legal requirements. CE-marking therefore is one of the most important objectives for manufacturers that want to distribute medical devices in Europe.

The authors are working in the medical devices industry for many years. With their expertise they provide a competent but also practice-oriented overview of the European and national requirements for medical devices. This book is meant to be a workbook including exercises to deepen the knowledge on the CE-marking process for medical devices.