Medical Devices

A medical device can mean any instrument, apparatus, implant, reagent or related article that is used to diagnose, prevent, or treat disease or other conditions, which does not achieve its purposes through chemical action within or on the body (which would make it a drug). Medical devices play a crucial role in helping to prevent disease, guide treatment and improve the quality of life of those with disabilities.

Whereas medicinal products (or more simply, drugs) work mainly through action by pharmacological, metabolic or immunological means, medical devices act by other means like physical, mechanical, or thermal.

Medical devices vary greatly in terms of complexity from very simple ones like wooden tongue depressors, bandages or latex surgical gloves to complex and computerised ones such as deep brain stimulators.

They also vary enormously in their purpose, including things as diverse as artificial limbs to thermometers. Some medical devices such as pacemakers, insulin pumps, operating room monitors, defibrillators and even some surgical instruments, (like deep-brain stimulators or smart surgical blades), can transmit vital health information directly from a patient’s body to the medical professional treating them. Some of these devices can be remotely controlled.

Before a medical device can be made available in Europe, they need to obtain a CE mark, which indicates that the device meets all European legal and safety essential requirements. A clinical study may or may not be involved to demonstrate that the device meets these requirements. Even after a device has got its CE mark, further clinical studies may be done to better evaluate the potential benefits of the device and the views of people using the device in practice. The ethical issues involved in medical device trials are broadly similar to those involved in drug trials but there are some differences in terms of study design and regulatory approvals.