RESEARCH ARTICLE
Application of Regulation (EU) 2017/745 of the European Parliament and of the Council to artificial intelligence
1
Jagiellonian University
Publication date: 2024-10-08
PPM 2022;4(1):145-164
KEYWORDS
ABSTRACT
This paper presents the general shape of the regulation of Regulation (EU) 2017/745 of the European Parliament and of the Council dedicated to software in healthcare and applied to AI software. It addresses issues of the general characteristics of MDR applied to software, including the definition of a medical device in Regulation 2017/745 with regard to artificial intelligence, the criteria for qualifying AI software as a medical device. It also addresses systemic problems as well as existing and proposed mandatory and soft law regulations.
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| eISSN: | 2719-3748 |
| ISSN: | 2657-8573 |
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