Svempe Liga
Faculty of Social Sciences, Riga Stradins University, Riga, Latvia.
JMIR Med Inform. 2024 Sep 5;12:e58080. doi: 10.2196/58080.
In light of rapid technological advancements, the health care sector is undergoing significant transformation with the continuous emergence of novel digital solutions. Consequently, regulatory frameworks must continuously adapt to ensure their main goal to protect patients. In 2017, the new Medical Device Regulation (EU) 2017/745 (MDR) came into force, bringing more complex requirements for development, launch, and postmarket surveillance. However, the updated regulation considerably impacts the manufacturers, especially small- and medium-sized enterprises, and consequently, the accessibility of medical devices in the European Union market, as many manufacturers decide to either discontinue their products, postpone the launch of new innovative solutions, or leave the European Union market in favor of other regions such as the United States. This could lead to reduced health care quality and slower industry innovation efforts. Effective policy calibration and collaborative efforts are essential to mitigate these effects and promote ongoing advancements in health care technologies in the European Union market. This paper is a narrative review with the objective of exploring hindering factors to software as a medical device development, launch, and marketing brought by the new regulation. It exclusively focuses on the factors that engender obstacles. Related regulations, directives, and proposals were discussed for comparison and further analysis.
鉴于技术的快速进步，随着新型数字解决方案的不断涌现，医疗保健行业正在经历重大变革。因此，监管框架必须不断调整，以确保其保护患者的主要目标。2017年，新的《欧盟医疗器械法规》（EU）2017/745（MDR）生效，对医疗器械的开发、上市和上市后监管提出了更复杂的要求。然而，更新后的法规对制造商，尤其是中小企业产生了重大影响，进而影响了欧盟市场上医疗器械的可及性，因为许多制造商决定要么停产其产品，推迟推出新的创新解决方案，要么离开欧盟市场转而青睐美国等其他地区。这可能导致医疗保健质量下降和行业创新努力放缓。有效的政策校准和合作努力对于减轻这些影响并促进欧盟市场医疗保健技术的持续进步至关重要。本文是一篇叙述性综述，旨在探讨新法规给软件作为医疗器械的开发、上市和营销带来的阻碍因素。它专门关注那些造成障碍的因素。对相关法规、指令和提案进行了讨论，以便进行比较和进一步分析。
