Through a broad literature review, analysis of EU, USA, Ukraine regulation acts, scientific research, and opinions of progressive-minded people in this sphere, this paper provides a guide to understanding the essence of classification of stand-alone software with medical purpose and specifics of its regulation. This research is based on dialectical, comparative, analytic, synthetic, and comprehensive methods.
Keywords: applications; apps; authorized body; classification; legislation; medical devices; medical devices directive; medical devices regulation; software; classification.