Ludvigsen, Kaspar Rosager; Nagaraja, Shishir; Daly, Angela - 2021
clearer We see this with the medical device legislation, specifically the Medical Device Regulation (MDR) not being explicitly … device in EU law, more specifically in the Medical Device Regulation. To do this, we first create a framework for the … medical device at all. We show how and where software is specifically mentioned in the regulation, and how it is understood …