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<p>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 factors. The financial burden was the most common challenge, with 31 respondents (88.6%) reporting a significant or severe impact. The regulation causes delays, the new clinical evidence requirements are challenging, and the process requires more resources. 6 companies (23.1% of those planning a launch) have canceled a new product launch, while 8 (34.8% of companies with 2 or more products) have discontinued an existing product. 6 respondents (17.1%) are exiting the EU market, and 10 companies (28.6%) are considering shutting down their operations. 16 respondents (45.7%) consider certification not worthwhile if the buyers are individual consumers.</p>

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Impact of the new European medical device regulation on digital health manufacturers

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月26日

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摘要

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 factors. The financial burden was the most common challenge, with 31 respondents (88.6%) reporting a significant or severe impact. The regulation causes delays, the new clinical evidence requirements are challenging, and the process requires more resources. 6 companies (23.1% of those planning a launch) have canceled a new product launch, while 8 (34.8% of companies with 2 or more products) have discontinued an existing product. 6 respondents (17.1%) are exiting the EU market, and 10 companies (28.6%) are considering shutting down their operations. 16 respondents (45.7%) consider certification not worthwhile if the buyers are individual consumers.