Abstract
This study assessed the Medical Device Regulation EU 2017/745 impact on the digital health companies and the industry. An online survey was conducted in April-May 2025, targeting manufacturers registered in the EUDAMED database with a software-type product. 35 responses were received. The survey results empirically confirm the negative effect of the theoretically identified hindering fact...
This study employs a straightforward survey methodology to assess the impact of EU 2017/745 on digital health manufacturers, with a small but targeted sample of 35 respondents. The findings align with theoretical concerns about regulatory burdens, particularly financial and operational challenges. However, the sample size is modest, and the survey’s reliance on self-reported data from a specific subset of manufacturers (those already registered in EUDAMED) may introduce selection bias. The study...