Medical Device Regulation (MDR)

Medical Device Regulation (MDR) refers to a set of guidelines put in place by the European Union to ensure that medical devices are safe and effective for patients. It covers everything from surgical instruments to diagnostic equipment, ensuring they meet high standards before being sold. The MDR requires thorough testing, clear labeling, and ongoing monitoring of devices even after they’re on the market. These regulations aim to protect patients by making sure that any medical device used in healthcare meets rigorous safety and performance criteria.