ABSTRACT

Bioethics is a field that deals with issues related to life and health, especially in the biological sciences, medicine, and biotechnology. The development and evolution of these areas are without doubt continuous and it accelerates as it falls to the ground of economic prosperity and aging or growing population. Similar to the formation of the European Union, the history of bioethics can also be traced back to the period after the Second World War. The Nuremberg Code (1947) and the first bioethical guidelines, such as the Declaration of Helsinki (1964), defined the ethics of human experimentation. Nowadays, the EU has what the treaties call shared competencies to provide a legal framework for the challenges generated by technological development. However, knowing the legal system of the EU and considering its dynamics, it is reasonable to ask to what extent it is able to actively and proactively regulate the most dynamic areas of bioethics, and to what extent the provisions above nation-states only generate extra bureaucracy for the actors in the field.

KEYWORDS

bioethics | medical devices | MDR regulation | MDD regulation | clinical researches

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