Medical Devices (MD) and clinical investigations with MD;s

Medical Device refers to a wide range of non-medicinal products used in medicine and health care. These products do not affect directly the functioning of the body, are not absorbed or distributed in the human body, and do not leave the body through biological metabolism (excretion).

Devices include a variety of instruments (e.g. surgical special tools), hardware and software (e.g. intensive care monitoring devices), and surgically installed devices (e.g. hearing aids or pacemakers). In addition, the device may also refer to other products and materials used, for example, in laboratory examinations of samples (e.g. blood sample analysis), as well as products for external local treatment of the body (e.g. nasal sprays or eye drops). In addition, the devices can be so-called combination devices, which combine both the medicine and the device required to administer it (e.g. a powdered breathing device, inhaler used to treat asthma).

Investigations of medical devices assess the safety of the use of the device or its performance. All MD clinical investigations performed on patients are reported to the authorities (Fimea). In addition, a favorable opinion of the Medical Research Ethics Committee is always required. There must also always be a lead medical investigator (doctor) for each MD investigation.