The state agency emphasizes that the main purpose of the labeling of medical devices is to provide information about the medical device and its manufacturer, as well as the information about the safety and efficiency of the device, and about the intended user of the device (skilled specialist or other person without special qualification). Such information can be indicated on the device itself, on the packaging of the device or in the instruction for use.
The method, format, content, legibility and location of the label, as well as the instruction for use, must correspond to the specific device, its intended purpose, and provide information about the technical knowledge, experience, education or training of the intended user. In particular, the instruction for use must be written using terms that are easy to understand for its intended user and, where appropriate, it must be supplemented by drawings and diagrams. Some devices can contain specific information for professional users.
The information that has to be applied to the label must be placed on the device itself. If this is impossible or inappropriate, then all information or its part may be placed on the packaging for each item of goods and/or on the packaging of several items of goods. If the manufacturer supplies several products to one user and/or location, it can be sufficient to provide only one copy of the instruction for use. In this event, the manufacturer must provide further copies upon request.
The State Service of Ukraine on Medicines and Drugs Control notes that the instructions for use can be shortened for devices, if they can be used safely and for their intended purpose as designed by the manufacturer without such instructions.
They can also be provided to the user both in hard and soft copy. They can be provided in different ways either together with the device or separately from the device. The examples of other methods are information displayed on the screen of the device, information downloaded from the website of the manufacturer via the Internet and other sources. The chosen methods must ensure that the public has access to them. If instructions for use are provided on media other than paper, the manufacturer must provide the user with information about how to view such instructions; get access to the current version of the instruction; obtain a paper copy of the instruction for use.