Overview software MDR & IVDR (OSMI)
Below this text you can find (medical) software, related to the CE-Classification. This is a temporary overview until the international Eudamed database is launched. When the Eudamed database is ready, we will make sure this software overview will be reused as much as possible.
The goal of this software overview is to reduce the risk of software not meeting the Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) in time and to prevent hospitals contacting their suppliers, requesting the same information as others.
This OSMI platform is a collaboration of BMTZ and NVKI.