title: Certain aspects on medical devices software law regulation.
abstract: BACKGROUND
  some kind of easiness of entry in creating software products on various computing platforms has led to such products being made available perhaps without due consideration of potential risks to users and patients and the most valuable reason for this have been lack of regulatory clarity. Some key points on legal regulation of abovementioned sphere is a base of this study.
  
  
  METHODS
  Ukrainian legislation, European Union`s Guidelines on the qualification and classification of standalone software; Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices that works in United States of America. Article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods.
  
  
  CONCLUSIONS
  in accordance with Ukrainian legislation, software that has a medical purpose could be a medical device. Ukrainian legislation which is established on European Union Medical Devices Directives divide all medical devices on classes. But there aren't any special recommendations or advices on classifications for software medical devices in Ukraine. It is necessary to develop and adopt guidelines on the qualification and classification of medical device software in Ukraine especially considering the harmonization of Ukrainian legislation with the EU legislation, develop special rules for the application of the national mark of conformity for medical device software and defined the « responsible organization » for the medical device software approval process.
authors.affiliation: Poltava Law Institute Of Yaroslav Mudryi National Law University, Poltava, Ukraine.
authors.forename: Vitalii
authors.initials: V
authors.lastname: Pashkov
authors.affiliation: Poltava Law Institute Of Yaroslav Mudryi National Law University, Poltava, Ukraine.
authors.forename: Andrii
authors.initials: A
authors.lastname: Harkusha
mesh_terms: D004864:Equipment and Supplies; D005062:European Union; D006801:Humans; D061214:Patient Safety / Q000331:legislation & jurisprudence*; D012984:Software / Q000145:classification / Q000331:legislation & jurisprudence* / Q000592:standards; D014455:Ukraine
keywords:  qualification and classification;  responsible organization ; medical purpose software