Individualized medical device engineering, such as 3D-manufacturing, point-of-care manufacturing, AI-powered personalized software, but also companion diagnostics, is a key element of personalized medicine. The interactive workshop, “Regulatory paths for personalized medical devices – challenges and implementation concepts“, provides an information exchange forum at the interface between the possibilities of biomedical engineering and regulatory requirements in the field of personalized medical devices. Based on the current understanding of the regulatory framework in this field, case studies will be used to present and discuss the challenges and possible solutions for placing personalized medical devices on the European market.