Regulations and Reimbursement of Software as a Medical Device in Europe Part 2
Market entry and regulatory landscape
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.