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Regulations and Reimbursement for Software as a Medical Device in Europe Part 3
Reimbursement of SaMD in Europe
Dec 06, 2023

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 this third part, we cover both the current reimbursement pathways for SaMD in Europe (by looking into the pioneering countries with systematic pathways for reimbursement of digital health solutions such as DiGA in Germany), as well as explore the expected development in the reimbursement of digital healthcare in Europe in the coming years (by taking a look at the various national initiatives and governments' efforts in countries such as France and the UK, that only recently became the leaders).

Part 1 – Definitions & Regulatory Challenges

We explore SaMD definition, it's challenges and the ways the regulatory bodies try to address them.

Part 2 – Market Entry & Regulatory Landscape

In part 2, we discuss SaMD regulations specifically in Europe, covering Medical Device Software (MDSW) regulations.

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