Regulace uvádění zdravotnických prostředků na trh

This diploma thesis deals with the topic concerning regulation of launching medical devices onto the market with regard to the analysis of key regulatory framework. The aim of the thesis is to find out if the legal framework really fulfils its de lege ferenda objectives. The purpose of this thesis is to confirm or disprove a hypothesis that the regulation of launching medical devices onto the market is sufficient and effective from the point of view of consumer protection and interests of other stakeholders. Secondary aim of this diploma thesis is to confirm or disprove a hypothesis that the harmonization of legal framework in the EU is appropriate and effective. These hypothesis are to a certain extent following up the verification of four essential goals that should be reached by the regulation. One of the key aims is assuring the safety of the products, enabling them to move freely in terms of the internal market of the EU and assuring that the consumer isn't misled when deciding about his optimal situation. Besides that the regulation shouldn't unnecessarily slow down the activities of businesses and inappropriately limit their innovation potential. The diploma thesis has a critical point of view concerning some aspects of this regulation and in the end the author suggests some proposals in order to improve the current practice.