JMIR Publications

ABSTRACT

In light of rapid technological advancements, the healthcare 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 a new Medical Device Regulation 2017/745 (hereinafter - MDR) came into force, bringing more complex requirements for development, launch, and post-market surveillance. However, the updated regulation considerably impacts the manufacturers, especially SMEs, and consequently, the accessibility of medical devices in the EU market, as many manufacturers decide to either discontinue their products, postpone the launch of new innovative solutions, or leave the EU market in favor of other regions such as the US. This could lead to reduced healthcare quality and slower industry innovation efforts. Effective policy calibration and collaborative efforts are essential to mitigate these effects and promote ongoing advancements in healthcare technologies in the EU. The objective of this paper was to explore hindering factors to software as a medical device (SAMD) development, launch, and marketing brought by the new regulation. It exclusively emphasizes factors that engender obstacles. Related regulations, directives, and proposals were discussed for comparison and further analysis.