There are general labeling requirements for medical devices, which are considered to be the minimum requirements for all devices. There are, however, additional requirements specific to certain device categories. The content of a product label and its instructions for use have profound impact on its liability. For instance, it informs the end user about warnings and hazards associated with the device.

Medical device labeling consists of the information provided by the manufacturer and may be presented in words and/or as symbols. Labeling can be placed on the product itself, on packaging (such as in the case of sterile medical devices), the outer box, displays and on instructions for use (products inserts, user manual, maintenance and installation guidelines).

Some countries have different language requirements for labeling. Over the counter (non-prescription) devices have special requirements.

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