Medical devices are indispensable for the health care sector – in the hospital as well as in the doctor´s office. They are used worldwide to save lives, to restore health or prevent the patient´s condition from deteriorating. The safety and efficiency of the medical device is therefore of high importance. The CE-mark that is affixed to medical device is a visible sign that this product meets the essential requirements that are laid down in three major directives that will be discussed later on. This CE-mark is like a “passport” for a medical device that allows the device to “travel” within the European Union. Therefore manufacturers – who want to sell their products in Europe – strive for getting the CE-mark. This book does not only want to give a theoretical overview of the process of getting the CE-mark and of its importance. It also strives to demonstrate via exercises the practical benefit of this knowledge. You will come acquainted with the major aspects of the European directives and the implementation of these directives into national law. In Germany this law is called Medizinproduktegesetz (MPG, Medical Device Act). Moreover, you will learn about the responsibilities and obligations of manufacturers of medical devices, about the criteria for product classification, on conformity assessment procedures and many more. After reading the book and working on the exercises you will be able to decide what method applies to your product. Information on relevant standards is given as well. In the end, you will be acquainted with the major aspects and regulations of the CE-marking process for your medical device.weiterlesen