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.
Keywords
- Technical File
- Device Need
- In Vitro Diagnostics (IVDs)
- Clinical Investigation Plan
- Medical Devices Vigilance System
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.
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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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