The regulation of medical devices: A comparative study of American and EEC Law

Part I of this thesis will describe the regulation of medical devices in the EEC. Before coming to the actual medical device legislation, a description of the legislative system in Europe will be given, to the extent that it is relevant for the Directives on medical devices. After dealing with the history of Directives and their current contents, the status of the Directives and their future prospects will be discussed. Part II will deal with the regulation of medical devices in the United States under the Food Drug & Cosmetic Act as amended by Medical Device Amendments of 1976. First, the history of the regulation for medical devices will be examined. Next the regulatory system in the United States and the problems that arose with its implementation will be elaborated. The latter section also will touch upon recent developments. Part III will identify the differences between the European and American systems and the problems that these differences might cause manufactures of the medical devices in Europe and the United States. Possible solutions to those problems, particularly with respect to the European system, will be suggestions in the last section of the third part. Finally, a conclusion will summaries the observation of the previous parts