Abstract

The subject of this article is legal analysis of a new type of medicinal products, called digital medicines. The article refers to the procedure launched by the FDA (USA) for considering the application for the marketing of the first digital medicine in the history of the Agency. The author analyzes the legal status of this kind of medicines on the basis of the EU directive and national regulations. The legal analysis has been based not only on the provisions of law, but also the jurisprudence of the Court of Justice of the European Union. Also definitions of a medical device were considered. The last part covers the role digital medicines could play for the establishment of the new reimbursement system and health care services, as well as de lege ferenda conclusions.