A medical device is an instrument or machine in vitro reagent, computer application or other related article projected by the maker to be utilized in humans, alone or in the combination with other instruments, for one or more of the purposes mentored below;
Diagnosis, prevention, monitoring, treatment or relief of a disease or injury, research, replacement, modification or support of the anatomy or physiological process, support or maintenance of life, control of conception and disinfection of the medical devices.
Types of Medical Devices
They are the instruments planned for the surgical usage i.e. to cut, pierce, saw, scrape, hold, remove, immobilize without any connection with another active medical device.
It is the substance, article or material used for the diagnosis, treatment or prevention of diseases for use and does not require any energy sources.
It is the operational medical device that gathers systems and electrical, electronic and hydraulic subsystems and/or hybrids, which for use require a source of energy including the software that is involved in the smooth operation.
Medical Device in Vitro Diagnostic
- These are purposed by the maker to conduct the examination of samples derived from the human body and it can be used alone as well as in a combination for in vitro examination of samples primarily for the following purposes;
- To give information on a physiological or pathological condition or congenital anomaly.
- To monitor the security and compatibility with a potential receiver.
- To supervise the therapeutic measures applied.
Classification of Medical Devices
The classification of each medical devices depends on many accepts such as the duration of contact of the medical device with the human organism, degree of invasiveness, whether the medical device provides medication or energy to the patient, if it is intended to have a biological effect in the patient, whether it is used alone or in combination, may influence the classification of the medical device.
In accordance with the Regulation of Control of Products and Elements of Medical Use DS 825/1998, medical devices are grouped into 4 classes according to the level of risk associated with their use.
It has the medical devices with a very low degree of risk.
It has the medical devices with a moderate level of risk.
This class has medical devices with a high risk potential.
It includes medical devices considered to be the most critical in terms of risks.