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THE IQVIA INSTITUTE

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"Global Trends in R&D 2024

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Building on a rich history of developing AI for healthcare, IQVIA AI connects the right data, technology, and expertise to address the unique needs of healthcare. It's what we call Healthcare-grade AI.

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IQVIA Decentralized Trials deliver purpose-built clinical services and technologies that engage the right patients wherever they are. Our hybrid and fully virtual solutions have been used more than any others.

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WHITE PAPER
Regulations and Reimbursement of Software as a Medical Device in Europe Part 2
Market entry and regulatory landscape
Apr 20, 2023
  • Library
  • Regulations and Reimbursement of Software as a Medical Device in Europe Part 2
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Over the past few decades, the development in software used alone or together with a medical device has increased significantly, this is due, in part, to the increased adoption of smart technology such as smartphones, wireless connectivity, cheaper and better sensors, cloud computing, big data and Artificial Intelligence (AI),  which are influencing healthcare delivery across the world.

In part 2, we discuss Software as a Medical Device regulations specifically in Europe. We cover Medical Device Software (MDSW) regulations under the EU MDR and the EU IVD, how is it different from the SaMD definition, and we also highlight the key market entry challenges for digital health solutions into the European market.

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