Regulations and Reimbursement of Software as a Medical Device in Europe- Part1

Over the past decades, the development in software used alone or together with a medical device has significantly increased. This is due 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 alerting healthcare delivery across the world. With the advancement of these technologies leading to a shift in how healthcare is administered and delivered, software has become an essential component of the development of medical devices. Particularly "Stand alone" software or "Software as a Medical Device (SaMD)" has seen fast growth recently as there is no hardware involved, fewer constraints as well as the use of fast feedback loops for improvement.

In Part 1 of this publication series, we explore SaMD definition, it's challenges and the ways the regulatory bodies try to address them, as well as the expected development of regulations related to Artificial Intelligence (AI) and Machine Learning (ML) in SaMD.