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The Regulation Of Medical Devices: A Comparative Study Of American And Eec Law, Martine Carliese Pijnappels

LLM Theses and Essays

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, …