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

Līga Svempe (Corresponding Author)

Research output: Contribution to journalArticlepeer-review

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Abstract

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.
Original languageEnglish
Article numbere58080
JournalJMIR Medical Informatics
Volume12
DOIs
Publication statusPublished - 5 Sept 2024

Keywords*

  • Digital health
  • Artificial Intelligence
  • medical device regulation
  • Software
  • rights

Field of Science*

  • 3.3 Health sciences
  • 5.2 Economy and Business
  • 5.5 Law

Publication Type*

  • 1.1. Scientific article indexed in Web of Science and/or Scopus database

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