Innovation contributes to better healthcare by providing, for example, less invasive treatments, early identification techniques, and self/home-monitoring devices. However, bringing valuable and relevant innovations to users is challenging.
Many medical innovations and technology fail to get CE marking, and the majority of products receiving a CE mark disappear within two years of certification, because they fail implementation and upscaling. This is partly caused by regulations that do not clearly define which studies to conduct or what evidence to gather. Much will change when new and stricter EU regulations (MDR/IVDR) take effect, providing an opportunity to do better.