The Medical Device Directive (MDD) is a set of regulations established by the European Union to ensure the safety and effectiveness of medical devices. It outlines the requirements for the design, manufacturing, and marketing of these devices, which include items like surgical instruments and diagnostic equipment. The directive aims to protect public health while facilitating innovation in the medical device industry. Under the MDD, manufacturers must conduct thorough assessments and provide documentation to demonstrate compliance with safety standards. The directive also mandates that devices be labeled correctly and that users receive adequate information about their use. This regulatory framework helps maintain high-quality standards in the healthcare sector.