Abstract
Similar to drugs, medical devices need to be approved before being CE-marketed. Clinical data, so-called preclinical data, have to be obtained and gathered, and a technical file has to be compiled including a clinical evaluation. In some cases, clinical trials have to be conducted before the approval of the medical device due to lacking of clinical data. This chapter defines medical devices: it describes the regulatory context of approval, the most important parts of the technical file, and the ways and methods of clinical testing required to get the medical device approved and on the market.
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Wettlaufer, L., Penn, D. (2018). Medical Devices: Definition and Clinical Testing. In: Hock, F., Gralinski, M. (eds) Drug Discovery and Evaluation: Methods in Clinical Pharmacology. Springer, Cham. https://doi.org/10.1007/978-3-319-56637-5_70-1
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DOI: https://doi.org/10.1007/978-3-319-56637-5_70-1
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