Medical device labeling is the process of providing important information about a medical device to the user, typically through labeling on the device or in accompanying documentation. Medical device labeling is critical to ensuring that users can use the device safely and effectively.

Device labeling may include information such as the device’s intended use, its indications for use, instructions for use, warnings and precautions, contraindications, and information on the device’s performance and technical specifications. Labeling may also include information about the device manufacturer, such as contact information and regulatory compliance.

In many countries, including the United States and European Union, device labeling is regulated by government agencies to ensure that the labeling is accurate, comprehensive, and understandable to users. Medical device manufacturers are typically required to follow strict guidelines for the content and format of device labeling.

Effective device labeling is important not only for ensuring patient safety, but also for ensuring that healthcare providers can use the device correctly and efficiently. Clear and concise labeling can reduce the risk of errors and complications during medical procedures, ultimately leading to better outcomes for patients.