Exploring Impediments Imposed by the Medical Device RegulationEU 2017/745 on Software as a Medical Device

In light of rapid technological advancements, the health care sector is undergoing significant transformation with the continuousemergence of novel digital solutions. Consequently, regulatory frameworks must continuously adapt to ensure their main goalto protect patients. In 2017, the new Medical Device Regulation (EU) 2017/745 (MDR) came into force, bringing more complexrequirements for development, launch, and postmarket surveillance. However, the updated regulation considerably impacts themanufacturers, especially small- and medium-sized enterprises, and consequently, the accessibility of medical devices in theEuropean Union market, as many manufacturers decide to either discontinue their products, postpone the launch of new innovativesolutions, or leave the European Union market in favor of other regions such as the United States. This could lead to reducedhealth care quality and slower industry innovation efforts. Effective policy calibration and collaborative efforts are essential tomitigate these effects and promote ongoing advancements in health care technologies in the European Union market. This paperis a narrative review with the objective of exploring hindering factors to software as a medical device development, launch, andmarketing 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