Abstract
INTRODUCTION: The majority of developed countries are currently experiencing demographic aging. The most frequently expressed concerns related to the changing age structure are the increased costs of social and medical care, a lack of labor force in the job market, and financial sustainability of the pension system. These concerns are often based on the pessimistic view of population aging. This view understands aging as a prolonged period of illness and suffering. On the other hand, optimists believe that a longer life span is a result of increased quality of life and better health care. The quality of life may be improved not only by medicaments, but also by rapidly developing area of medical devices, which allow better care for seniors in many areas. AIM: This contribution aims to assess the legislative environment and ethical questions related to the use of medical devices, especially medical devices, in medical care for senior citizens. METHODS: The methods used in this study are literature reviews of legislative and ethical environment in the European Union (EU) and the US. RESULTS: Main findings of this study result from assessing the state of medical device regulations in Europe and the US. Namely, the US regulation seems to be better arranged, which is probably due to the fact that there is only one responsible body - the US Food and Drug Administration, which is responsible for all medical device regulations. On the other hand, in the EU, talks about new legislation are led by ministers from all the EU member states and it may take a long time before all the EU countries come to an agreement.