We have manufacturers, suppliers and service providers from the area Labeling for medical devices

In accordance with the MDR, all medical devices must include instructions on their use, as well as a description of the risks and benefits. For example, suction equipment, intravenous infusion pumps, physical therapy equipment, and transdermal electrical nerve stimulation (TENS) devices must include their warnings and directions for use. A prescription medical device must also include information on the risk/benefit ratio. These warnings must be legible, and the label must remain attached during the normal manufacturing process.

The label is also a means of educating users about the risks and benefits of using the device. It also provides accurate information about the safe and effective use of the device. Considering that many of these devices are used in the home, proper label application is critical to the safety of the product. The presence of a visual inspection system helps ensure that the labels are properly applied. Furthermore, it makes conducting recalls easier. Therefore, it is crucial to ensure that all labels are accurate and presentable.

Some types of medical devices do not require labelling. Examples of these devices include an ordinary toothbrush used for oral hygiene and non-medicated adhesive bandages. But other types of medical devices need labelling. For example, a prefilled syringe, for example, is not required to include a warning on its packaging. But it must provide a complete overview of the clinical trials that were conducted before the device was approved for sale.

Medical device labeling is a complex process. The requirements differ from country to country, so companies must check the regulations in each one before beginning their product manufacturing. Gilero is a trusted partner for manufacturers of medical devices. A comprehensive review of your device's labeling will result in a compliant product. The report will include suggestions for graphic design, claims modifications, and more. A qualified team of experts will make recommendations on the labeling process that will help your product meet the required regulations.

The information on the labeling of a medical device is essential. It must include the intended use, IFU, and manufacturer's address. Moreover, the IFU must be easy to read and understand. In addition, the IFU should be legible and easy to understand. The labels should also contain the name and address of the manufacturer. These factors are important for both consumers and manufacturers, but they should not be confused. The FDA has published a standard for medical device labeling.

The labels of medical devices are regulated by the FDA. All medical devices sold in Canada must have a label. Single-use devices, investigational testing devices, and custom-made devices do not need to be labeled. However, it is essential to have a clear and precise label on these products. You should also follow the manufacturer's instructions for safety and effectiveness. This way, you can ensure that your products are safe and comply with the law.