Medical Device Regulation in Europe – OMC Medical Limited

Introducing the Medical Device Regulation in Europe addresses several challenges. The primary objective of the MDR is to prioritize patient safety. By introducing more stringent requirements for conformity assessment, clinical evidence, and post-market surveillance, the regulation aims to reduce the risk of harm to patients and users of medical devices. The MDR promotes transparency by introducing measures such as the European Database on Medical Devices (EUDAMED).