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Revista de Bioética y Derecho
versão On-line ISSN 1886-5887
Resumo
PUIG HERNANDEZ, Marc. Some reflections on the Oviedo Convention and medical devices. Liability and certification in the case of cyborgs. Rev. Bioética y Derecho [online]. 2021, n.51, pp.299-320. Epub 29-Mar-2021. ISSN 1886-5887.
The Oviedo Convention constitutes a generic framework for the various applications of biomedicine on human beings. If, on the one hand, its orders are of generic application, it must be combined, on the other hand, with other special regulations which regulates particular activities or specific areas. In this study, we question the fit between the generic framework of the Oviedo Convention and the regulation of medical devices, in particular, we focus on the application of such products on the human body, meanly, their integration into the body. This is the case of cyborgs, or the theme already coined under the term transhumanism. Our reflection leads us to evaluate the different standards and to offer a certification proposal based on the liability regime for this type of products.
Palavras-chave : Oviedo Convention; medical devices; cyborgs; liability; certification.