Abstract. Shaping a reliable and effective legal framework that would not hinder innovation and quick access of consumers to innovative devices and at the same time guarantee the safety of these devices and their benefits for patients, users or third parties at an equally high level is an important element of the legislative regulation of the procedure for admission of medical devices to the market and implementation of control over their circulation. Analysis of EU legislation in terms of regulations aimed at ensuring the safety and effectiveness of medical devices and facilitating patient access to them, as well as the experience of EU member states which have established control over safety, quality, use, introduction into market, supply, compliance assessment, clinical trials and studies of the effectiveness of medical devices in accordance with the legislation are of significant interest to Ukraine. The analysis covered Ukrainian legislation in the field of medical devices circulation, in particular, state guarantees in the field of healthcare and ensuring high level safety for medical devices consumers, as well as the legislation of the European Union, Austria, Estonia, Latvia, Lithuania, Germany, Poland and Czech Republic.

Key words: medical devices, circulation of medical devices, ensuring the safety of consumers of medical devices, Regulation (EU) 2017/745, EUDAMED database of the European Union on medical devices.

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05/2023