Samenvatting

The Medical Device Regulation (MDR) came into effect in May 2021. Compared to its predecessor (the Medical Device Directive), the scope and definition of software has been expanded, and medical software often falls into a higher risk classification. For developers of health technology, healthcare organisations, research institutes, and education this has a major, often underestimated, impact. The MDR sets high standards for safety and efficiency of medical devices.
We investigated the impact of the MDR on an ongoing project, in which Virtual Reality (VR) applications are developed for rehabilitation care. In this abstract we share our lessons learned that also apply to health technology research and development.