Medical Devices

Medical device is every instrument, apparatus, appliance, material or other device used alone or in combination, including the software for diagnostic or therapeutic purposes that are intended by the manufacturer and necessary for their proper use. Medical devices do not achieve their primary intended action in or on the human body by pharmacological, immunological or metabolic means, although their action may be assisted by such means. They are intended for:

1. diagnosis, prevention, monitoring, treatment or alleviation of disease
2. diagnosis, prevention, monitoring, treatment, alleviation or compensation for an injury or handicap
3. investigation, replacement or modification of the anatomy or of a physiological process
4. control of conception.

 „Invitro diagnostic medical devicesincluding reagents, reagent products, calibrators, control materials, kits, instruments, apparatuses, equipment or systems, whether used alone or in combination, are intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information about:

1. physiological or pathological state;
2. congenital abnormalities;
3. the safety and compatibility of a potential recipient;
4. data necessary for monitoring therapeutic effects.

In our country, this area is regulated by the Law on Medicines and Medical Devices BiH (Official Gazette of BiH, No. 58/08) and the Regulations on Medical Devices (Official Gazette of BiH, No. 04/10).

There are more than 900 000 different types of medical devices, and for this reason they are classified in various ways. Medical devices are classified according to the duration of the contact of the medical device with the user, the degree of risk in relation to the users, the degree of invasiveness of medical devices, the use of medical devices, application site of medical devices, method of use of medical devices...

According to the level of risk medical devices are grouped into:

a) Class I - low risk for users

b) Class IIa - medium risk for users

c) Class IIb - high risk for users

d) Class III - highest risk for users.

Based on the nature of a medical device, its connection to an energy source and other characteristics, medical devices can be:

a) non-invasive medical devices (which are not in contact with the user or are in contact only with intact skin);

b) invasive medical devices (which penetrate the body through the skin, natural or artificial openings);

c) active medical devices (which are used separately or in combination with other medical devices and provide data for the detection of irregularities, diagnosis, monitoring or treatment of physiological disorders, illnesses or congenital anomalies).

Based on the duration of application in or on the human body, medical devices can be:

a) Transient use (intended for continuous use no longer than 60 minutes);

b) Short-term use (intended for continuous use for no more than 30 days);

c) Long-term use (intended for continuous use for more than 30 days).

According to the method and place of issuance, medical devices are classified into:

a) medical devices which are issued with prescription / order only in pharmacies and specialized stores;

b) medical devices which are issued without a prescription only in pharmacies and specialized stores;

c) medical devices which are issued with prescription / order in hospital pharmacies;

d) medical devices which are sold without a prescription in free sale;

e) medical devices that are issued with a medical service.

„In vitro“- diagnostic medical devices are classified as follows:

1. a. "In vitro" - diagnostic medical devices which are used by qualified personnel and that are according to the type of assets divided into List A and B;
2. b. "In vitro" - diagnostic medical devices for self-testing;
3. c. other "in vitro" diagnostic medical devices.

For easier classification, and considering their purpose, all medical devices are divided into several categories:

• Active surgical implants,
• Anesthetic and respiratory medical devices,
• Dental medical devices,
• Medical electro-mechanical means,
• Hospital equipment
• "In vitro" medical devices,
• Active surgical implants,
• Ophthalmic and optical medical devices,
• Reusable Instruments,
• Disposable Medical devices,
• Technical devices for disabled persons,
• The diagnostic and therapeutic medical devices in radiology,
• Additional therapeutic medical devices,
• Medical devices of biological origin,
• Medical software, etc.

Manufacturing process of medical devices follows the rapid development of other branches of science, such as medicine, biology, electrical engineering, electronics, information technology and many others. Development of medical devices and the need that people have for it, is going in the direction of constructing functional, fully equipped, aesthetically acceptable and high-quality medical devices. In recent years there has been great progress in the production and achieved quality of medical devices.

Medical devices are multicomponent systems, and the failure in function of one system can lead to the dysfunction of the entire medical device, and unfortunately to the major consequences for the health of the users, and can even cause serious consequences such as disability and death. Post-marketing surveillance and reporting of side effects are an important way of monitoring the quality of medical devices and it is an important factor in ensuring the quality of medical devices for all users who are rapidly expanding in number.

• The list of medical devices for which certificates of registration have been issued in the Register of Medical Devices

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• The list of medical devices for which certificates of registration have been issued in the Register of Medical Devices from 09/12/2017

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