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DEFINITION AND DIVISION OF MEDICAL DEVICES
A Medical Device represents:b) A diagnostic medical device in vitro, involving a reagent, a reagent product, control and calibration material, a kit, an instrument, an apparatus, equipment or a system used independently or under combination intended for tests under in vitro conditions, including blood and transplant tissues obtained from human organisms, with the intention to secure information related to:
- Physiological or pathological states;
- Congenital anomalies;
- Determining the safety and the compatibility of the potential recipient of the transplant;
- Monitoring therapeutic measures;
Devision
Theese medical devices shall be classified:
| 1 | LIST A |
| -Reagents and reagents products, including control and calibration materials for determining the following blood types: ABO system, Rhesus (C, c, D, E, e) anti-Kell | |
| -Reagents and reagents products, including control and calibration materials for determining, confirming and quantifying HIV infection markers (HIV 1 and 2), HTLV I and II, and hepatitis B, C and D in human material | |
| 2 | LIST B |
| -Reagents and reagents products, including control and calibration materials for determining the following blood types: anti-Duffy and anti-Kidd | |
| -Reagents and reagents products, including control and calibration materials for determining precluded anti-erythrocyte antibodies | |
| -Reagents and reagents products, including control and calibration materials for determining and quantifying similar infections: rubella, toxoplasmosis and others in human material | |
| -Reagents and reagents products, including control and calibration materials for diagnosing the following hereditary diseases: phenolketonouria | |
| -Reagents and reagents products, including control and calibration materials for determining the following human infections: cytomegalovirus, chlamydia | |
| -Reagents and reagents products, including control and calibration materials for determining the following HLA tissue groups: DR, A, B | |
| -Reagents and reagents products, including control and calibration materials and control materials for determining the following tumor markers: PSA | |
| -Reagents and reagents products, including control and calibration materials and software for determining the specifics of the hereditary risk of trisomy 21 | |
| 3 | PRODUCT FOR SELF-TESTING |
| -Auxiliary products for self-diagnosis, including materials for control and calibration: blood sugar measuring preparations | |
| 4 | ALL OTHER DIAGNOSTIC DEVICES |
Kriterijume za razvrstavanje medicinskih sredstava propisuje ministar nadležan za poslove zdravlja, a za medicinska sredstva koja se upotrebljavaju isključivo u veterinarskoj medicini, propisuje ministar nadležan za poslove veterine.