Medical devices

General Medical Devices

General medical device means any instrument, apparatus, appliance and product intended to be used, alone or in combination, for human beings for the following purpose:

1) Diagnosis, prevention, monitoring, treatment or alleviation of disease,
2) Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
3) Investigation, replacement or modification of the anatomy or of a physiological process,
4) Control of conception,
A medical device is also considered to be a device which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
General medical devices include accessories which are not considered to be a medical device by definition and refer to products which when used together with the medical device enable the functioning of such medical device in accordance with its intended purpose specified by the manufacturer.
General medical devices also include custom-made devices which are specifically manufactured in accordance with the prescription of the appropriate health-care professional intended for the sole use of a particular patient.

General medical devices are classified as follows:
1) Based on the risk for the user:
– Class I – Medical devices with the low level of risk for the user;
– Class II(a) – Medical devices with a medium level of risk for the user;
– Class II(b) – Medical devices with a high level of risk for the user;
– Class III – Medical devices with the highest level of risk for the user.
2) Based on the nature of a medical device, its connection to an energy source and other characteristics, medical devices can be:
– Non-invasive;
– Invasive; and
– Active.
3) Based on the duration of application in or on the human body, medical devices can be:
– Transient use (intended for continuous use no longer than 60 minutes);
– Short-term use (intended for continuous use for no more than 30 days);
– Long-term use (intended for continuous use for no less than 30 days).

In vitro Diagnostic Medical Devices

In vitro diagnostic medical devices include any reagents, reagent products, control and calibration materials, reagent kits, instruments, apparatuses, equipment or systems, used independently or in combination, intended to be used in In vitro conditions for the examination of samples, including blood and tissue samples from the human body, in order to obtain the following information:

• Concerning physiological or pathological state;
• Concerning congenital abnormalities;
• For determining the safety and compatibility of a potential recipient;
• For monitoring therapeutic measures.

Specimen containers are considered to be in vitro diagnostic medical devices, i.e. vacuum‐type device or non-vacuum-type for the primary containment and preservation of samples derived from the human body for the purpose of in vitro diagnostic examination.
A self-testing device refers to any in vitro diagnostic medical device intended to be used by an unskilled person in their environment.
Performance evaluation device refers to any in vitro diagnostic medical device intended to be a subject of one or more studies for performance evaluation conducted in medical analysis laboratories or in any other appropriate environment outside its own premises.
Calibrator and control material refer to any substance, material or product intended for determining measuring proportions or testing performance properties of a certain device in relation to its originally intended purpose.
In vitro diagnostic medical devices do not include products intended for general laboratory use, unless these products are specifically intended for use in in vitro diagnostic testing by the manufacturer.

Classification of Diagnostic Medical Devices

1) A list:
– Reagents and reagent products including the materials for control and calibration used for determining the following blood types: ABO blood group system, Rhesus Factor (C, c, D, E, e) “anti‐Kell”;
– Reagents and reagent products including the materials for control and calibration used for detection, confirmation and quantisation of HIV infection markers (HIV 1 and 2), HTLV I and II, and Hepatitis B, C, D in human samples.

2) B list:
– Reagents and reagent products, as well as the materials for control and calibration used for determining of the following blood types: “anti‐Duffy” and “anti‐Kidd”;
– Reagents and reagent products, as well as the materials for control and calibration used for detection of the unacceptable anti‐erythrocyte antibodies;
– Reagents and reagent products, as well as the materials for control and calibration used in detecting and quantifying similar infections: Rubella, Toxoplasmosis, and the like in human samples;
– Reagents and reagent products, as well as the materials for control and calibration used for the diagnosis of hereditary diseases (Phenylketonuria);
– Reagents and reagent products, as well as the materials for control and calibration used for detecting human infections (Cytomegalovirus and Chlamydia);
– Reagents and reagent products, as well as the materials for control and calibration used for determining HLA tissue groups (DR, A, B);
– Reagents and reagent products, materials for control and calibration, as well as the control materials for determining tumour markers (PSA);
– Reagents and reagent products, as well as the materials for control and calibration, and the software for determining the specificity of the hereditary risk for trisomy 21;
– Products for self‐diagnosis, as well as the materials for control and calibration (products for measuring blood sugar levels);
3) In vitro diagnostic medical devices for SELF‐TESTING;
4) OTHER in vitro diagnostic medical devices.

Active Implantable Medical Devices

Active implantable medical devices are the products whose actions depend on the source of electricity or any other energy sources that are not powered directly from the human body or gravity, and are intended to be either fully or partially introduced into the human body by surgical intervention, or to be permanently placed in the body openings.