Patient safety means a condition in which a patient does not suffer any unnecessary actual harm, nor is exposed to any potential harm related to healthcare. The World Health Organization’s recognition of patient safety, as one of the most important factors in determining high quality healthcare, initiated the systematic introduction of changes in the approach to this issue, both globally and on the level of individual healthcare service providers. In order to enhance the quality and ensure the safety of healthcare services provided, national, European Union, and worldwide institutions focus on the introduction of a so-called patient safety culture. The creation of this safety culture would not be possible without the establishment of its legal framework. The purpose of this article is to shed light on the legislative achievements of the European Union within patient safety, taking into consideration acts that summarize the level of implementation of individual recommendations. This study can be useful both for those who focus their scientific interests on the subject of patient safety and those who need concise information on the legislative measures of the Community in this respect, as well as for medical personnel who want to become acquainted with this issue without reading comprehensive legal acts.

This is Open Access article distributed under the terms of the Creative Commons Attribution-ShareAlike 4.0 International. IntroductionThe COVID-19 pandemic has contributed to significant changes in social and economic life all over the world. However, the direct impact of the pandemic

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