European Union Medical Device Regulation

The European Union Medical Device Regulation (EU MDR) is a set of rules that ensure medical devices sold in Europe are safe and effective. It updates previous laws to improve quality, transparency, and accountability, requiring manufacturers to conduct thorough testing, provide detailed technical documentation, and monitor devices after they reach the market. This regulation helps protect patients and healthcare professionals by ensuring that only devices meeting high safety standards are used, while also making manufacturers more responsible for their products throughout their lifecycle.