Regulation and Its Impact on Innovation in Healthcare: SAMD Case

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