What question did this study set out to answer?

To analyze regulatory and legal frameworks governing medical device software in Ukraine and the EU and identify key differences and challenges.

Regulatory and legal regulation of software of medical devices in the legislation of Ukraine and the EU

View Full Paper

Ask AI

Bookmark

Authors

Analytical review highlights regulatory differences and improves risk classification for software in medical devices.

To analyze regulatory and legal frameworks governing medical device software in Ukraine and the EU and identify key differences and challenges.
Conducted an analytical review of regulatory acts in Ukraine and the EU related to medical devices and software.
Focused on aspects regarding the classification and conformity assessment of medical device software.
Noted increased instances of software as integral or stand-alone medical devices in recent years.
Identified uncertainties in Ukraine's regulations regarding the risk classification of software as medical devices.
EU Regulation 2017/745 has addressed some classification uncertainties, introducing clearer risk assessments.

Kharchenko et al. (2025) studied this question.

View Full Paper

Ask AI

Bookmark