Abstract
Digitalisation in healthcare can transform the industry, thus a new product development shall be supported and promoted by stakeholders. Healthcare is also a heavily regulated industry to ensure safety of the end-users – the patients.
The aim of this article is to analyse regulation of software as a medical device (SAMD) in Europe in the light of recently introduced Regulation (EU) 2017/745 (MDR). The analysis starts with defining what SAMD is and how it is classified, as well as how the classification has changed according to the new regulation. As the new rules significantly change the classification for most of the SAMDs, their impact on the innovation process is explored from the perspective of the innovators and the market. Furthermore, the regulation of AI solutions in the medtech industry is also explored.
The analysis also covers how the SAMD can launch updates to be compliant with the regulatory requirements. Several obstacles in the innovation process have been identified and explored.