Selected Legal Aspects of the Process of Developing and Introducing a New Technology for the Needs of Aesthetic Medicine in the Eu Based on the MDR Regulation

Abstract Technological developments in the 21st century continue to bring us new treatment solutions that often go beyond the limits set by legal regulations. In particular, medicine and cosmetology in the European Community clash with each other, exceeding their typical procedures. The most important consideration is patient safety while fulfilling their wishes to improve their appearance, which affects their overall health. One of the most important legal acts related to this issue is Regulation (EU) 2017/745 of the European Parliament and of the Council of April 5, 2017, on medical devices (...). A professional analysis of this regulation is necessary from the very moment when the idea of using practical observations or an idea to introduce a new technology to the medical services market arises. This article presents selected objectives of the Regulation and basic issues related to the procedure for placing a product on the market in accordance with the interpretation of its provisions. The content of the analyzed regulations provides a basis for the key issues indicated in the summary of the article, which result from them for the development and introduction of innovations in the field of aesthetic medicine, such as the correct categorization of the product or the conduct of clinical trials.