Pediatric Medical Device investigations

As with medicines, too few medical devices suitable for children are available for therapeutic use. Most of the current medical equipment is intended for adult care. Because diseases in children are different from those in adults and children are of different sizes at different stages of development, medical devices have often had to be used against their official instructions for use (the so-called ‘off-label’, like medicines), for example by mechanically reducing the size of the device or the size of the parts associated with the device itself, in order to make it fit into smaller parts of the body (e.g. blood vessels). Therefore, the product development and availability of children’s and young people’s medical devices should be increased through clinical trials to provide medical devices specifically designed and suitable for the care of children, as well as safe and high-quality medical devices.

However, designing and examining medical devices in children is often a challenge. Children are often more active than adults and body structures and functions change during growth. In addition, children may need the device for a very long time, until adulthood, which places different demands on the longevity of the device and long-term quality materials.

Before the start of the MD investigation, the study plan must include comprehensive information on the clinical needs of the patient group being studied, and a careful risk and benefit assessment must be carried out on the medical device. The MD type must be known, the intended clinical use, duration of use, and the possible effects of the intended use on the child’s growth, development, and overall health. The study plans should also use previous adult research data on the performance and safety of the devices, if available, as these can be used to make prognoses and conclusions about the use of the device in children, if the device has the same intended use and the health status of the children being treated is similar to that of adults. If the new device is targeted only at, for example, newborns or to follow the developmental stages of young children, there is no adult study data available, because the studies in question cannot be done in adults.